Purpose
To evaluate the response rate and safety of superselective drug-eluting beats transarterial chemoembolization (DEB-TACE) with doxorubicin-loaded 40-µm microspheres in patients with ...hepatocellular carcinoma (HCC).
Methods
One hundred and forty-one treatments with doxorubicin-loaded 40-µm microspheres in 83 patients between 2012 and 2017 were retrospectively evaluated. Images of the treated lesions were analyzed before and after each treatment according to mRECIST (modified Response Evaluation Criteria in Solid Tumors). Therapy response (complete response CR + partial response PR) and disease control (CR + PR + stable disease SD) rates were determined, and the correlation between the longitudinal axis (longest diameter of the tumor) and volume was investigated using a newly developed software for systematic tumor response assessment. Additional endpoints were progression-free survival (PFS) and time to progression (TTP).
Results
In the target tumors, a therapy response rate of 63.1% and a disease control rate of 95.7% were achieved. There was a good correlation between the measurement of the longitudinal axis and volume of the measured lesion (
r
value, 0.954). The median PFS was 2.23 months, and the median TTP was 5.91 months. The serious adverse event rate (SAE) was 10.64%.
Conclusion
Superselective DEB-TACE with 40-µm sized Embozene Tandem™ can be considered an effective and safe treatment, given the number of procedure-related complications.
Paclitaxel-coated balloons (DCB) are suitable to reduce the risk of restenosis after angioplasty of atherosclerotic femoropopliteal lesions. However, numerous types of DCBs are distinguished by drug ...density and coating. Conflicting evidence exists about the risk of mortality. This study sought to evaluate benefit and risk of DCB angioplasty compared to plain old balloon angioplasty (POBA).
Randomised trials published between January 1, 2005 and February 3, 2019 were identified by searching MEDLINE, CENTRAL, and Clinical.trials.gov. Studies on DCB versus POBA for the treatment of femoropopliteal artery disease were included, and those focused on in-stent restenosis or critical limb ischemia were excluded. Random-effects meta-analysis was conducted to assess the main outcomes of freedom from target lesion revascularisation (FfTLR) and all-cause mortality.
Of 552 identified records, 14 studies including 2504 patients were eligible. DCB significantly increased the risk of FfTLR with substantial heterogeneity (12-month: risk ratio RR 1·24 95% CI 1·14–2·27, I2 = 66%; 24-month RR 1·39 95% CI 1·39–1·52, I2 = 21%). The risk of 24-month all-cause mortality was increased after DCB (random-effects model: RR 1·53 95% CI 0·94–2·50, p = 0·09; fixed-effect model: RR 1·74 95% CI 1·08–2·81, p = 0·02).
Efficacy of DCB differs substantially across studies. Effect size depends on the type of DCB, treatment strategy, and lesion complexity. The risk of 2-year all-cause mortality at 2 years was increased, but without evidence of causation.
Abstract
Background
Endovascular revascularization has established as the first-line therapy of femoropopliteal artery disease. Paclitaxel-coated balloon angioplasty proved to be superior to plain ...old balloon angioplasty (POBA) regarding prevention of restenosis and need for recurrent revascularization. Over the past years, paclitaxel was the only active drug to inhibit neointimal proliferation which could be processed to an appropriate balloon coating. The purpose of this study is to assess whether efficacy and safety of sirolimus-coated balloon angioplasty is noninferior to paclitaxel-coated balloon angioplasty.
Methods
This randomized controlled, single-blinded, multicentre, investigator-initiated noninferiority trial aims to enrol a total of 478 participants with symptomatic femoropopliteal artery disease of Rutherford category 2 to 4 due to de novo stenosis or restenosis. After pre-dilation, participants will be allocated in a 1:1 ratio to either sirolimus- or paclitaxel-coated balloon angioplasty. Post-dilation with the drug-coated balloon (DCB) used or standard balloon is mandatory in case ≥ 50%, and optional in case of ≥ 30% residual diameter stenosis. Bailout stenting with bare-metal nitinol stents should be conducted in case of flow-limiting dissection. Primary noninferiority endpoints are primary patency and the composite of all-cause mortality, major target limb amputation, and clinically driven target lesion revascularization at 12 months. Secondary outcomes are clinical and hemodynamic improvement, change in health-related quality of life, and safety throughout 60 months.
Discussion
Although concerns about long-term safety of paclitaxel-coated devices were not confirmed by recent patient-level data analyses, conflicting evidence contributed to a loss of confidence among patients and physicians. Therefore, sirolimus, known for a broader therapeutic range than paclitaxel, may serve as a welcome alternative. This will be justified if noninferiority of sirolimus-coated balloon angioplasty against the current standard of paclitaxel-coated balloon angioplasty can be demonstrated.
Trial registration
ClinicalTrials.gov
NCT04475783
. Registered on 17 July 2020
EUDAMED No. CIV-20-11-035172,
DRKS00022452
This study aimed to investigate performance, effectiveness, and safety of excimer laser atherectomy for the treatment of complex lower limb artery disease in a real-world setting.
In our prospective, ...multicenter registry, consecutive patients with complex lower limb lesions underwent excimer laser atherectomy with optional standard balloon angioplasty, paclitaxel-coated balloon angioplasty, and bailout stenting. Primary outcome was technical success. Secondary outcomes were device performance of the excimer laser system, freedom from target lesion revascularization (TLR), peri-procedural complications, and amputation-free survival in patients with critical limb ischemia (CLI).
A total of 294 patients were enrolled at 14 European centers (mean lesion length 109±103 mm, total occlusions 56.8% 167 of 294 lesions, CLI 47.3% 132 of 279 patients. Adjuvant balloon angioplasty was conducted in 283 (96.3%), and complementary stent implantation in 98 patients (33.3%). Technical success was achieved in 95.3% of patients. Increasing lesion length was associated with decreased laser atherectomy performance (odds ratio OR per 10 mm: 0.94 95% confidence interval CI 0.90 to 0.99, P=0.01). A total of 66 patients (22.4%) completed the 12-month follow-up. Freedom from TLR was 83.5% (95% CI: 74.9 to 92.1) at 12 months. Chronic total occlusions were associated with more TLR (OR 5.03 95% CI: 1.01 to 25.1, P=0.049). Amputation -free survival in patients with CLI was 93.1% (95% CI: 83.9 to 100).
Excimer laser atherectomy substantially contributed to technical success of endovascular treatment of complex infra-inguinal lesions. Freedom from 12-month TLR was reasonable.
Purpose
To assess radiation exposure in men undergoing prostate artery embolization (PAE) for the treatment for symptomatic, benign prostatic hyperplasia depending on growing experience of ...interventional radiologists over a 4-year period.
Methods
A total of 250 consecutive patients underwent PAE at a single center. Data on radiation exposure dose area product (DAP), effective dose (ED), entrance skin dose (ESD), and fluoroscopy time (FT) were retrospectively evaluated. Primary outcomes of interest were patient radiation exposure in five consecutive groups of 50 patients each and Pearson correlation with the number of patients treated.
Results
Median DAP, ED, and ESD during prostate artery embolization were significantly higher in the first compared to the second 50 patients (56 298 µGym
2
vs. 24 709 µGym
2
,
p
< 0.001, 146.4 mSv vs. 64.2 mSv,
p
< 0.001, and 5.1 Gy vs. 2.4 Gy,
p
< 0.001, respectively). The following consecutive groups did not differ significantly from the respective preceding group in terms of DAP, ED, and ESD. Number of digital subtraction angiography series, FT, and procedure time decreased with increasing operator experience (Pearson’s
r
= − 0.240,
p
< 0.001,
r
= − 0.269,
p
< 0.001, and
r
= − 0.504,
p
< 0.001, respectively). Bilateral prostate artery embolization was associated with less ESD and shorter FT than unilateral embolization (median 2.5 vs. 3.5 Gy,
p
= 0.02, and 26 min vs. 42 min,
p
< 0.001, respectively).
Conclusion
Exposure to radiation in men who underwent PAE decreased with growing operator experience and decreasing complexity of procedures.
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.
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.
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).
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.
While it is the most common thoracic venous anomaly, a persistent left vena cava superior may present in atypical variations, which are important to consider during clinical management.
Here we ...report a 35-year-old Caucasian female patient with drainage into the left atrial appendage who presented with shortness of breath accompanied by mild hypoxemia. Venous contrast filling in the context of pulmonary scintigraphy suspected an additional superior caval vein connected to the left atrial appendage. Diagnosis was confirmed by transesophageal echocardiography. Cardiac catheterization revealed a minor right-to-left shunt. The symptoms could be allocated to a bronchial asthma and treated according to guidelines. Cerebral lesions detected in the patient were due to a coincident multiple sclerosis rather than cerebral embolisms. Thus, the venous anomaly was classified as an incidental finding currently requiring no treatment.
To the best of our knowledge, this is the first report of a persistent left vena cava superior draining into the left atrial appendage.
Holmium-166 microspheres are used for the transarterial radioembolization (TARE) treatment of primary and secondary liver cancers. In this study, its efficacy regarding local tumor control and ...integration into the oncological treatment sequence of the first 20 patients treated in our institution were examined. A total of twenty-nine
Ho-TARE procedures were performed to treat hepatocellular carcinoma (HCC, fourteen patients), metastatic colorectal cancer (mCRC, four patients), intrahepatic cholangiocarcinoma (ICC, one patient), and hemangioendothelioma of the liver (HE, one patient). In eight patients,
Ho-TARE was the initial oncologic treatment. In patients with HCC, the median treated-liver progression-free survival (PFS), overall PFS, and overall survival after
Ho-TARE were 10.3, 7.3, and 22.1 months; in patients with mCRC, these were 2.6, 2.9, and 20.6 months, respectively. Survival after
Ho-TARE in the patients with ICC and HE were 5.2 and 0.8 months, respectively. Two patients with HCC were bridged to liver transplantation, and one patient with mCRC was downstaged to curative surgery. In patients with HCC, a median treatment-free interval of 7.3 months was achieved. In line with previous publications,
Ho-TARE was a feasible treatment option in patients with liver tumors, with favorable clinical outcomes in the majority of cases. It was able to achieve treatment-free intervals, served as bridging-to-transplant, and did not prevent subsequent therapies.
Primary hyperparathyroidism is a rare condition of disease which can seldomly present as giant retrotrhyroideal cysts, complicating the localization of the adenoma to resect.
A 56-year old female ...presented with hypercalcaemia of 3.38 mmol/L (2.2-2.65 mmol/L) and a history of breast cancer. A fast growing cystic parathyroidal adenoma was diagnosed by a multimodal approach including comprehensive diagnostic imaging (ultrasonography, scintigraphies, dynamic MRI) and cytopathological investigations after ultrasonography-guided puncture. The patient was cured by surgical extraction of the whole adenoma. In retrospect, the rapid growth was most likely induced by cinacalcet (initially 30 mg/d, later 60 mg/d) therapy which the patient received for few months only. Primary hyperparathyroidism was ascertained because surgical removal of the solitary adenoma cured the patient. Furthermore, there was no relevant renal insufficiency or history of prolonged calcium-level deregulation.
This phenomenon of cystic degeneration of parathyroidal adenoma under therapy with cinacalcet has previously been described in secondary hyperparathyroidism, but not in primary hyperparathyroidism and should be considered in diagnostic approach.
Transarterial radioembolization (TARE) with 166Ho-loaded microspheres is an established locoregional treatment for hepatocellular carcinoma (HCC), introduced in 2010. This study evaluates the ...clinical outcome of patients with HCC who underwent 166Ho-TARE with personalized dosimetry. Twenty-seven patients with 36 TARE procedures were analyzed. Treatment planning, execution, and evaluation was possible without complications in all cases. At the 3-month follow-up, disease control in the treated liver was achieved in 81.8% of patients (complete remission, partial remission, and stable disease in 36.4%, 31.8%, and 13.6%, respectively). The median overall survival (OS) was 17.2 months, and progression-free survival (PFS) in the treated liver was 11 months. Statistically significant positive correlations were observed between the achieved radiation dose for the tumor and both PFS (r = 0.62, p < 0.05) and OS (r = 0.48, p < 0.05), suggesting a direct dose–response relationship. The calculated achieved dose was 8.25 Gy lower than the planned dose, with relevant variance between planned and achieved doses in individual cases. These results confirm the efficacy of the 166Ho-TARE holmium platform and underscore the potential of voxel-based, personalized dosimetry to improve clinical outcomes.
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