The #HOPE4LIVER Single-Arm Pivotal Trial for Histotripsy of Primary and Metastatic Liver Tumors.

Background Histotripsy is a nonthermal, nonionizing, noninvasive, focused US technique that relies on cavitation for mechanical tissue breakdown at the focal point. Preclinical data have shown its safety and technical success in the ablation of liver tumors. Purpose To evaluate the safety and technical success of histotripsy in destroying primary or metastatic liver tumors. Materials and Methods The parallel United States and European Union and England #HOPE4LIVER trials were prospective, multicenter, single-arm studies. Eligible patients were recruited at 14 sites in Europe and the United States from January 2021 to July 2022. Up to three tumors smaller than 3 cm in size could be treated. CT or MRI and clinic visits were performed at 1 week or less preprocedure, at index-procedure, 36 hours or less postprocedure, and 30 days postprocedure. There were co-primary end points of technical success of tumor treatment and absence of procedure-related major complications within 30 days, with performance goals of greater than 70% and less than 25%, respectively. A two-sided 95% Wilson score CI was derived for each end point. Results Forty-four participants (21 from the United States, 23 from the European Union or England; 22 female participants, 22 male participants; mean age, 64 years ± 12 [SD]) with 49 tumors were enrolled and treated. Eighteen participants (41%) had hepatocellular carcinoma and 26 (59%) had non-hepatocellular carcinoma liver metastases. The maximum pretreatment tumor diameter was 1.5 cm ± 0.6 and the maximum post-histotripsy treatment zone diameter was 3.6 cm ± 1.4. Technical success was observed in 42 of 44 treated tumors (95%; 95% CI: 84, 100) and procedure-related major complications were reported in three of 44 participants (7%; 95% CI: 2, 18), both meeting the performance goal. Conclusion The #HOPE4LIVER trials met the co-primary end-point performance goals for technical success and the absence of procedure-related major complications, supporting early clinical adoption. Clinical trial registration nos. NCT04572633, NCT04573881 Published under a CC BY 4.0 license. Supplemental material is available for this article. See also the editorial by Nezami and Georgiades in this issue.

The Prevalence of Sarcopenia in Patients with Solid Tumors Differs Across Regions: A Systematic Review.

Objective: The purpose of the meta-analysis was to compare the prevalence of sarcopenia on staging computed tomography (CT) in patients with solid tumors in different world regions. Materials and Methods: MEDLINE, Embase, and SCOPUS literature databases were screened for prevalence of sarcopenia in oncologic patients up to December 2022. Two hundred eighty studies met the inclusion criteria. The methodological quality of the involved studies was checked according to the Quality Assessment of Diagnostic Studies instrument. Results: Two hundred eighty studies with 81,885 patients were included. The prevalence of sarcopenia among all patients was 35.5%. Prevalence of sarcopenia was higher in Europe (45.6%) and North America (41.2%) than in Asia (29.6%). Prevalence rates for the curative cohort were similar in all three regions, with 43.7% in Europe, 41.3% in North America, and 37.4% in Asia. In the palliative cohort, sarcopenia prevalence was higher in Europe (55.7%) and Asia (45.7%) than in North America (34.0%). In the European cohort, prostate cancer (73.9%), esophageal cancer (74.2%), pancreatic cancer (62.5%), and renal cell cancer (65.3%) showed high prevalence rates of sarcopenia. Applied cutoff values differed among regions. Conclusion: Our study shows that prevalence rates for sarcopenia of patients with solid tumors differ between regions and are different for curative and palliative settings. European studies demonstrate high prevalence rates for both settings. There is need for regional harmonization of sarcopenia definitions.

Diffusion-weighted MRI (DWI) for assessment of response to high-dose-rate CT-guided brachytherapy (HDR-BT) of hepatocellular carcinoma.

BACKGROUND: High-dose-rate computed tomography (CT)-guided brachytherapy (HDR-BT) has shown promising results in patients with hepatocellular carcinoma (HCC). While growing evidence shows clear limitations of mRECIST, diffusion-weighted imaging (DWI) has relevant potential in improving the response assessment. PURPOSE: To assess whether DWI allows evaluation of short- and long-term tumor response in patients with HCC after HDR-BT. MATERIAL AND METHODS: A total of 22 patients with 11 non-responding HCCs (NR-HCC; local tumor recurrence within two years) and 24 responding HCCs (R-HCC; follow-up at least two years) were included in this retrospective bi-center study. HCCs were treated with HDR-BT and patients underwent pre- and post-interventional magnetic resonance imaging (MRI). Analyses of DWI were evaluated and compared between pre-interventional MRI, 1.follow-up after 3 months and 2.follow-up at the time of the local tumor recurrence (in NR-HCC) or after 12 months (in R-HCC). RESULTS: ADCmean of R-HCC increased significantly after HDR-BT on the first and second follow-up (ADCmean: 0.87 ± 0.18 × 10-3 mm2/s [pre-interventional]: 1.14 ± 0.23 × 10-3 mm2/s [1. post-interventional]; 1.42 ± 0.32 × 10-3 mm2/s [2. post-interventional]; P < 0.001). ADCmean of NR-HCC did not show a significant increase from pre-intervention to 1. post-interventional MRI (ADCmean: 0.85 ± 0.24 × 10-3 mm2/s and 1.00 ± 0.30 × 10-3 mm2/s, respectively; P = 0.131). ADCmean increase was significant between pre-intervention and 2. follow-up (ADCmean: 1.03 ± 0.19 × 10-3 mm2/s; P = 0.018). There was no significant increase of ADCmean between the first and second follow-up. There was, however, a significant increase of ADCmin after 12 months (ADCmin: 0.87 ± 0.29 × 10-3 mm2/s) compared to pre-interventional MRI and first follow-up (P < 0.005) only in R-HCC. CONCLUSION: The tumor response after CT-guided HDR-BT was associated with a significantly higher increase in ADCmean and ADCmin in short- and long-term follow-up.

Thrombectomy versus Medical Management for Isolated Anterior Cerebral Artery Stroke: An International Multicenter Registry Study.

Background Evidence supporting a potential benefit of thrombectomy for distal medium vessel occlusions (DMVOs) of the anterior cerebral artery (ACA) is, to the knowledge of the authors, unknown. Purpose To compare the clinical and safety outcomes between mechanical thrombectomy (MT) and best medical treatment (BMT) with or without intravenous thrombolysis for primary isolated ACA DMVOs. Materials and Methods Treatment for Primary Medium Vessel Occlusion Stroke, or TOPMOST, is an international, retrospective, multicenter, observational registry of patients treated for DMVO in daily practice. Patients treated with thrombectomy or BMT alone for primary ACA DMVO distal to the A1 segment between January 2013 and October 2021 were analyzed and compared by one-to-one propensity score matching (PSM). Early outcome was measured by the median improvement of National Institutes of Health Stroke Scale (NIHSS) scores at 24 hours. Favorable functional outcome was defined as modified Rankin scale scores of 0-2 at 90 days. Safety was assessed by the occurrence of symptomatic intracerebral hemorrhage and mortality. Results Of 154 patients (median age, 77 years; quartile 1 [Q1] to quartile 3 [Q3], 66-84 years; 80 men; 94 patients with MT; 60 patients with BMT) who met the inclusion criteria, 110 patients (median age, 76 years; Q1-Q3, 67-83 years; 50 men; 55 patients with MT; 55 patients with BMT) were matched. DMVOs were in A2 (82 patients; 53%), A3 (69 patients; 45%), and A3 (three patients; 2%). After PSM, the median 24-hour NIHSS point decrease was -2 (Q1-Q3, -4 to 0) in the thrombectomy and -1 (Q1-Q3, -4 to 1.25) in the BMT cohort (P = .52). Favorable functional outcome (MT vs BMT, 18 of 37 [49%] vs 19 of 39 [49%], respectively; P = .99) and mortality (MT vs BMT, eight of 37 [22%] vs 12 of 39 [31%], respectively; P = .36) were similar in both groups. Symptomatic intracranial hemorrhage occurred in three (2%) of 154 patients. Conclusion Thrombectomy appears to be a safe and technically feasible treatment option for primary isolated anterior cerebral artery occlusions in the A2 and A3 segment with clinical outcomes similar to best medical treatment with and without intravenous thrombolysis. © RSNA, 2023 Supplemental material is available for this article. See also the editorial by Zhu and Wang in this issue.

Validation of clinical-radiological scores for prognosis of mortality in acute pulmonary embolism.

INTRODUCTION: Acute pulmonary embolism (APE) is a hazardous disorder with a high mortality. Combination of clinical, radiological, and serological parameters can improve risk stratification of APE. Most of the proposed combined scores were not validated in independent cohorts. Our aim was to validate the proposed clinical-radiological scores for prognosis of 7- and 30-day mortality in APE. MATERIALS AND METHODS: Our sample comprised 531 patients with APE, mean age 64.8 ± 15.6 years, 221 (41.6%) females and 310 (58.4%) males. The following parameters were collected: Age and sex of the patients, mortality within the observation time of 30 days, simplified pulmonary embolism severity index (sPESI), pH troponin level (pg/ml), minimal systolic and diastolic blood pressures (mmHg), heart rate, O2 saturation, episodes of syncope, and need for vasopressors. On CT pulmonary angiography (CTPA), short axis ratio right ventricle/left ventricle (RV/LV), and reflux of contrast medium into the inferior vena cava were obtained. The following clinical-radiological scores were calculated: BOVA score, pulmonary embolism mortality score (PEMS), European Society of Cardiology (ESC) score, Kumamaru score, and Calgary acute pulmonary embolism (CAPE) score. RESULTS: Overall, 31 patients (5.8%) died within seven and 64 patients (12%) within 30 days. All scores showed high negative prognostic values ranging from 89.0 to 99.0%. PEMS and CAPE score demonstrated the highest specificity for 7-day mortality (93.4% and 85.0%), PEMS and BOVA for 30-day mortality (94.2% and 90.4%). The highest sensitivity was observed for ESC 2019 (96.8% and 95.3%). Kumamaru and CAPE scores had low sensitivity. All scores had low positive and high negative predictive values. CONCLUSION: For prognosis of 7- and 30-day mortality in APE, PEMS score has the highest specificity. ESC 2019 shows the highest sensitivity. All scores had low positive and high negative predictive values.

Apparent diffusion coefficient for assessing Crohn's disease activity: a meta-analysis.

PURPOSE: To analyze relationships betweenapparent diffusion coefficient (ADC) and activity parameters of Crohn's disease, e.g., length and wall thickness, CRP, FCP, MaRIA, CDAI, SES-CD, histologic inflammatory activity score, and the histological fibrotic score, based upon published data. MATERIALS AND METHODS: MEDLINE library, Scopus, and Embase databases were screened for association between ADC and activity parameters of Crohn's disease in patients with Crohn's disease up to Mai 2021. Overall, 21 studies with 1053 patients were identified. The following data were extracted from the literature: number of patients, correlation coefficients between ADC and length as well as wall thickness, CRP, FCP, MaRIA, CDAI, and SES-CD, inflammatory activity score, and fibrotic score. Associations between ADC and activity parameters were analyzed by Spearman's correlation coefficient. The studies' methodologic quality was evaluated by using the Quality Assessment of Diagnostic Studies (QUADAS 2) instrument, revealing a low risk of bias. RESULTS: In the overall sample, the pooled correlation coefficient between ADC and CDAI was -0.8 (95% CI = [-0.94; -0.65]), between ADC and MaRIA -0.66 (95% CI = [-0.79; -0.53]). A strong association was observed between ADC and SES-CD with a pooled correlation of -0.66 (95% CI = [-0.87; -0.46]). The pooled sensitivity to discriminate between involved and non-involved bowel segments was 0.89, with an area under the curve of 0.89 CONCLUSIONS: ADC showed strong inverse correlations with CDAI, MaRIA, and SES-CD scores. However, the role of ADC in assessing fibrotic changes in the bowel wall is limited. ADC can reflect acute inflammatory reactions but not systemic inflammation. KEY POINTS: • ADC value can reflect acute inflammatory reactions but not systemic inflammation. • ADC is inversely correlated with CDAI, MaRIA, and SES-CD. • The role of ADC in assessing fibrotic changes in the bowel wall is limited.

Body Composition Predictors of Complicated Crohn's Disease.

BACKGROUND: High visceral adipose tissue (VAT) and creeping fat (CrF) in Crohn's disease (CD) have been widely recognized. The VAT to subcutaneous adipose tissue (SAT) ratio and sarcopenia have been associated with CD complications. Studies regarding the influence of body composition predictors on CD complications assessed with magnetic resonance enterography (MRE) are scarce. AIM: The aim of this study was to assess body composition parameters and CrF in opportunistic MRE as predictors of complicated CD. METHODS: This was a retrospective study of 114 patients with inflammatory (n = 54) and complicated (n = 60) CD. The semiautomated assessment of body composition and the qualitative evaluation of CrF were performed. RESULTS: Body composition parameters did not differ between both groups regarding the body mass index (p = 0.50), total adipose tissue index (TATI) (p = 0.14), subcutaneous adipose tissue index (SATI) (p = 0.17), visceral adipose tissue index (VATI) (p = 0.33), VAT/SAT ratio (p = 0.77), intramuscular adipose tissue (p = 0.64), skeletal muscle index (p = 0.22), and sarcopenia (p = 0.50). 47 strictures, 18 fistulae, and seven abscesses were identified. Fistulae were more likely to occur in patients with CrF (odds ratio [OR] 5.07, 95% confidence interval [CI] 1.76-14.56; p=<0.001) and high VAT/SAT ratio (OR: 3.82, 95% CI 1.34-10.85; p = 0.01). CONCLUSION: Body composition measurements in CD patients displayed no statistically significant difference between the groups of inflammatory and complicated disease. Nonetheless, CD patients stratified in the group of high VAT/SAT ratio and the presence of CrF should be recognized as risk groups for the occurrence of fistulae.

Interstitial Brachytherapy for Hepatocellular Carcinoma: Analysis of Prognostic Factors for Overall Survival and Progression-Free Survival and Application of a Risk Stratification Model.

INTRODUCTION: Interstitial brachytherapy (iBT) is an effective treatment for hepatocellular carcinoma (HCC). Identification of prognostic factors is pivotal for patient selection and treatment efficacy. This study aimed to assess the impact of low skeletal muscle mass (LSMM) on overall survival (OS) and progression-free survival (PFS) of iBT in patients with HCC. METHODS: For this single-center study, we retrospectively identified 77 patients with HCC who underwent iBT between 2011 and 2018. Follow-up visits were recorded until 2020. The psoas muscle area, psoas muscle index, psoas muscle density (MD), and the skeletal muscle gauge were assessed on the L3 level on pre-treatment cross-sectional CT scans. RESULTS: Median OS was 37 months. 42 patients (54.5%) had LSMM. An AFP level of >400 ng/ml (hazard ratio [HR] 5.705, 95% confidence interval [CI]: 2.228-14.606, p = 0.001), BCLC stage (HR 3.230, 95% CI: 0.972-10.735, p = 0.026), and LSMM (HR 3.365, 95% CI: 1.490-7.596, p = 0.002) showed a relevant association with OS. Weighted hazard ratios were used to form a predictive risk stratification model with three groups: patients with low risk (median OS 62 months), intermediate risk (median OS 31 months), and high risk (median OS 9 months). The model showed a good prediction of 1-year mortality, with an AUC of 0.71. Higher MD was associated with better PFS (HR 0.920, 95% CI: 0.881-0.962, p < 0.001). CONCLUSION: In patients undergoing iBT for HCC, LSMM is associated with worse OS. A risk stratification model based on LSMM, AFP >400 ng/mL, and BCLC stage successfully predicted patient mortality. The model may support and enhance patient selection.

Local ablation of hepatocellular carcinoma by interstitial brachytherapy: prediction of outcome by diffusion-weighted imaging.

BACKGROUND: Interstitial brachytherapy (iBT) has become a viable treatment option in the therapy of early and intermediate stage hepatocellular carcinoma (HCC). Prognostic imaging tools to predict patient outcome are missing. PURPOSE: To assess the predictive value of baseline diffusion-weighted imaging in HCC before iBT with regard to local tumor control and overall survival (OS). MATERIAL AND METHODS: We retrospectively identified 107 patients who underwent iBT for HCC from 2011 to 2018 from our database. Apparent diffusion coefficient (ADC) values for each treated lesion were analyzed in region of interest measurements. Additionally, explorative combined ratios adjusting total measured lesion area and mean measured lesion area per patient by ADC values were calculated. Measurements underwent a univariate and multivariate Cox regression analysis. The log rank test was then used to verify prognostic cutoff levels for median survival time. RESULTS: A total of 189 lesions in 81 patients were measured. Median survival of patients was 46.0 months. Neither ADC parameter was indicative of local tumor control. Lesion size >5 cm was associated with lower local tumor control (hazard ratio [HR]=4.292, 95% confidence interval [CI]=1.285-14.331; P = 0.018). Average measured lesion area divided by ADCmin (ADCarea mean, min) was identified to independently predict OS (HR=1.994, 95% CI=1.172-3.392; P = 0.011). A cutoff based on the variable's median (0.29 × 10-4 AU) identified patients with poor outcome (OS 36 vs. 61 months) for lower ADCarea mean, min values as verified by the log-rank test (P = 0.040). CONCLUSION: Pre-treatment ADCarea mean, min may serve as an independent predictor of OS in patients with HCC undergoing iBT.

Low skeletal muscle mass and post-operative complications after surgery for liver malignancies: a meta-analysis.

PURPOSE: To assess the influence of low skeletal muscle mass (LSMM) on post-operative complications in patients with hepatic malignancies grade (Clavien Dindo ≥ 3) undergoing resection. METHODS: MEDLINE, Cochrane, and SCOPUS databases were screened for associations between sarcopenia and major post-operative complications (≥ grade 3 according to Clavien-Dindo classification) after resection of different malignant liver tumors. RevMan 5.3 software was used to perform the meta-analysis. The methodological quality of the included studies was assessed according to the QUIPS instrument. RESULTS: The analysis included 17 studies comprising 3157 patients. Subgroup analyses were performed for cholangiocarcinoma (CCC), colorectal cancer (CRC) liver metastases, and hepatocellular carcinoma (HCC). LSMM as identified on CT was present in 1260 patients (39.9%). Analysis of the overall sample showed that LSMM was associated with higher post-operative complications grade Clavien Dindo ≥ 3 (OR 1.56, 95% CI 1.25-1.95, p < 0.001). In the subgroup analysis, LSMM was associated with post-operative complications in CRC metastases (OR 1.60, 95% CI 1.11-2.32, p = 0.01). In HCC and CCC sub-analyses, LSMM was not associated with post-operative complications in simple regression analysis. CONCLUSION: LSMM is associated with major post-operative complications in patients undergoing surgery for hepatic metastases and it does not influence major post-operative complications in patients with HCC and CCC.

Auditory Pathology in a Transgenic mtTFB1 Mouse Model of Mitochondrial Deafness.

The A1555G mutation in the 12S rRNA gene of human mitochondrial DNA causes maternally inherited, nonsyndromic deafness, an extreme case of tissue-specific mitochondrial pathology. A transgenic mouse strain that robustly overexpresses the mitochondrial 12S ribosomal RNA methyltransferase TFB1M (Tg-mtTFB1 mice) exhibits progressive hearing loss that we proposed models aspects of A1555G-related pathology in humans. Although our previous studies of Tg-mtTFB1 mice implicated apoptosis in the spiral ganglion and stria vascularis because of mitochondrial reactive oxygen species-mediated activation of AMP kinase (AMPK) and the nuclear transcription factor E2F1, detailed auditory pathology was not delineated. Herein, we show that Tg-mtTFB1 mice have reduced endocochlear potential, indicative of significant stria vascularis dysfunction, but without obvious signs of strial atrophy. We also observed decreased auditory brainstem response peak 1 amplitude and prolonged wave I latency, consistent with apoptosis of spiral ganglion neurons. Although no major loss of hair cells was observed, there was a mild impairment of voltage-dependent electromotility of outer hair cells. On the basis of these results, we propose that these events conspire to produce the progressive hearing loss phenotype in Tg-mtTFB1 mice. Finally, genetically reducing AMPK α1 rescues hearing loss in Tg-mtTFB1 mice, confirming that aberrant up-regulation of AMPK signaling promotes the observed auditory pathology. The relevance of these findings to human A1555G patients and the potential therapeutic value of reducing AMPK activity are discussed.

Evaluation of brain metastasis edema in breast cancer patients as a marker for Ki-67 and cell count-A single center analysis.

BACKGROUND: Peritumoral edema is an important cause of morbidity and mortality in patients with breast cancer brain metastases (BCBM). The relationship between vasogenic edema and proliferation indices or cell density in BCBM remains poorly understood. PURPOSE: To assess the association between tumor volume and peritumoral edema volume and histopathological and immunohistochemical parameters in BCBM. MATERIALS AND METHODS: Patients with confirmed BCBM were retrospectively identified. The tumor volume and peritumoral edema volume of each brain metastasis (BM) were semi-automatically calculated in axial T2w and axial T2-fluid attenuated inversion recovery (FLAIR) sequences using the software MIM (Cleveland, Ohio, USA). Edema volume was correlated with histological parameters, including cell count and Ki-67. Sub-analyses were conducted for luminal B, Her2-positive, and tripe negative subgroups. RESULTS: Thirty-eight patients were included in the study. There were 24 patients with a single BM. Mean metastasis volume was 31.40 ± 32.52 mL and mean perifocal edema volume was 72.75 ± 58.85 mL. In the overall cohort, no correlation was found between tumor volume and Ki-67 (r = 0.046, p = .782) or cellularity (r = 0.028, p = .877). Correlation between edema volume and Ki-67 was r = 0.002 (p = .989), correlation with cellularity was r = 0.137 (p = .453). No relevant correlation was identified in any subgroup analysis. There was no relevant correlation between BM volume and edema volume. CONCLUSION: In patients with breast cancer brain metastases, we did not find linear associations between edema volumes and immunohistochemical features reflecting proliferation potential. Furthermore, there was no relevant correlation between metastasis volume and edema volume.

Mortality and postinterventional complications after ablative treatment of liver malignancies: A cohort study of 4374 patients.

PURPOSE: Ablative therapies for primary and secondary liver malignancies are increasingly adopted in current guidelines. Nevertheless, surgical resection remains the gold standard in most curative therapy settings. Extensive studies on mortality and morbidity after ablative treatment of the liver are missing. We investigated complications and mortality after ablative treatment in a large, unselected study cohort. MATERIALS AND METHODS: Standardized patient and treatment data in 4374 percutaneous and angiographic ablative procedures of the liver from the DRG-based hospital reimbursement system (diagnosis-related groups) of an academic hospital in Germany were retrospectively evaluated. We analyzed descriptive patient data, length of stay (LOS), pre-existing medical conditions, previous gastrointestinal surgeries, severe complications, and occurrence of death. RESULTS: Treatment of secondary liver malignancies constituted over two-thirds of all procedures (71%, n = 3053). The mean LOS was 4.1 ± 3.5 days. Severe complications were documented in 1.4% and in-house death in 0.2% of cases, significantly more often after treatment with chemoembolization of primary liver malignancies (p = 0.003; p = 0.0001). Previous partial liver resection, partial bowel resection, and chronic renal failure were independent risk factors for the occurrence of severe complications. CONCLUSION: Severe complications and in-hospital death are rare in the treatment of primary and secondary liver malignancies with percutaneous and angiographic procedures. They are a viable alternative or addition to a surgical approach in treating liver lesions.

MRI-compatible and sensorless haptic feedback for cable-driven medical robotics to perform teleoperated needle-based interventions.

PURPOSE: Surgical robotics have demonstrated their significance in assisting physicians during minimally invasive surgery. Especially, the integration of haptic and tactile feedback technologies can enhance the surgeon's performance and overall patient outcomes. However, the current state-of-the-art lacks such interaction feedback opportunities, especially in robotic-assisted interventional magnetic resonance imaging (iMRI), which is gaining importance in clinical practice, specifically for percutaneous needle punctures. METHODS: The cable-driven 'Micropositioning Robotics for Image-Guided Surgery' (µRIGS) system utilized the back-electromotive force effect of the stepper motor load to measure cable tensile forces without external sensors, employing the TMC5160 motor driver. The aim was to generate a sensorless haptic feedback (SHF) for remote needle advancement, incorporating collision detection and homing capabilities for internal automation processes. Three different phantoms capable of mimicking soft tissue were used to evaluate the difference in force feedback between manual needle puncture and the SHF, both technically and in terms of user experience. RESULTS: The SHF achieved a sampling rate of 800 Hz and a mean force resolution of 0.26 ± 0.22 N, primarily dependent on motor current and rotation speed, with a mean maximum force of 15 N. In most cases, the SHF data aligned with the intended phantom-related force progression. The evaluation of the user study demonstrated no significant differences between the SHF technology and manual puncturing. CONCLUSION: The presented SHF of the µRIGS system introduced a novel MR-compatible technique to bridge the gap between medical robotics and interaction during real-time needle-based interventions.

The DERIVO 2 Heal Embolization Device in the Treatment of Ruptured and Unruptured Intracranial Aneurysms: a Retrospective Multicenter Study.

BACKROUND: The use of flow diverting stents in the treatment of intracranial aneurysms is associated with a risk of neurological morbidity due to their thrombogenicity. To reduce this risk different surface modifications have been developed. The Derivo 2 Embolization Device (Acandis, Pforzheim, Germany) has proven to be a safe and effective flow diverter. To overcome the risk of thrombo-embolism, the device was modified by adding an anti-thrombogenic fibrin-heparin coating. We aimed to assess the safety and effectiveness of the Derivo 2 heal Embolization Device. METHODS: Retrospective multicenter data from nine German neurovascular centers between February 2022 until December 2023 were used. Patients treated with the Derivo 2 heal Embolization Device for unruptured or ruptured intracranial aneurysms were included. Peri- and postprocedural adverse events, clinical outcomes, and angiographic follow-up results were evaluated. RESULTS: 84 patients (73.8% female; mean age 58.7 years) with 89 aneurysms (mean size 9.8 mm) were included. 87.6% were located in the anterior circulation. Most of them were sidewall aneurysms (88.8%). 96 flow diverters were used. 99.0% were successfully implanted. An in-stent balloon angioplasty was performed in 6.0% of the cases. An additional coiling was performed in 28.6%. Technical difficulties were present in 12.0% of the cases. Thrombotic events occurred in 4.8% with no neurological sequelae. Mortality and morbidity were 0 and 1.2% respectively. Adequate aneurysm occlusion was achieved in 80.7% with a mean follow-up time of 6.6 months. CONCLUSION: The Derivo 2 heal Embolization Device showed a satisfying aneurysm occlusion and safety with a low rate of neurological morbidity.

Endovascular revascularization of vertebrobasilar tandem occlusions in comparison to isolated basilar artery occlusions: A multi-center experience.

BACKGROUND: Acute basilar artery occlusion (BAO) is a severe disease that is associated with an 85% mortality rate if untreated. Several studies have analyzed the use of mechanical thrombectomy (MT) in the different scenarios of BAO. However, the results remain conflicting and the role of MT as standard of care for vertebrobasilar tandem occlusions (VBTO) has not been confirmed. Our goal was to assess technical feasibility, safety, and functional outcome of endovascular treatment of VBTO in comparison to isolated BAO (IBAO). METHODS: We retrospectively reviewed all prospectively collected patients with acute BAO from six tertiary centers between September 2016 and November 2021. Patients were subsequently divided into two groups: VBTO and IBAO. Baseline data, procedural details, and outcomes were compared between groups. RESULTS: A total of 190 patients were included, 55 presenting with a VBTO and 135 with IBAO. Successful recanalization was equally common in both groups (89.1% and 86.0%). Rates of favorable functional outcome (modified Rankin Scale: 0-2) were higher in patients with VBTO compared to IBAO (36.4% vs. 25.2%, p = 0.048) and mortality was lower (29.1% vs. 33.3%). However, these associations faded after adjustment for confounders (adjusted odds ratio [aOR] 0.86, 95% CI 0.35-2.05; aOR 0.93, 95% CI 0.35-2.45). Rates of symptomatic intracranial hemorrhage did not differ between the groups (VBTO: 7.3% vs. IBAO: 4.2%; p = 0.496). CONCLUSION: Endovascular treatment of VBTO is technically feasible and safe with similar rates of successful recanalization, favorable functional outcome, and mortality to those in patients with IBAO.

Impact of Vaccination Status on Outcome of Patients With COVID-19 and Acute Ischemic Stroke Undergoing Mechanical Thrombectomy.

BACKGROUND: Data on impact of COVID-19 vaccination and outcomes of patients with COVID-19 and acute ischemic stroke undergoing mechanical thrombectomy are scarce. Addressing this subject, we report our multicenter experience. METHODS AND RESULTS: This was a retrospective analysis of patients with COVID-19 and known vaccination status treated with mechanical thrombectomy for acute ischemic stroke at 20 tertiary care centers between January 2020 and January 2023. Baseline demographics, angiographic outcome, and clinical outcome evaluated by the modified Rankin Scale score at discharge were noted. A multivariate analysis was conducted to test whether these variables were associated with an unfavorable outcome, defined as modified Rankin Scale score >3. A total of 137 patients with acute ischemic stroke (48 vaccinated and 89 unvaccinated) with acute or subsided COVID-19 infection who underwent mechanical thrombectomy attributable to vessel occlusion were included in the study. Angiographic outcomes between vaccinated and unvaccinated patients were similar (modified Thrombolysis in Cerebral Infarction ≥2b: 85.4% in vaccinated patients versus 86.5% in unvaccinated patients; P=0.859). The rate of functional independence (modified Rankin Scale score, ≤2) was 23.3% in the vaccinated group and 20.9% in the unvaccinated group (P=0.763). The mortality rate was 30% in both groups. In the multivariable analysis, vaccination status was not a significant predictor for an unfavorable outcome (P=0.957). However, acute COVID-19 infection remained significant (odds ratio, 1.197 [95% CI, 1.007-1.417]; P=0.041). CONCLUSIONS: Our study demonstrated no impact of COVID-19 vaccination on angiographic or clinical outcome of COVID-19-positive patients with acute ischemic stroke undergoing mechanical thrombectomy, whereas worsening attributable to COVID-19 was confirmed.

Effect of anesthetic strategies on distal stroke thrombectomy in the anterior and posterior cerebral artery.

BACKGROUND: Numerous questions regarding procedural details of distal stroke thrombectomy remain unanswered. This study assesses the effect of anesthetic strategies on procedural, clinical and safety outcomes following thrombectomy for distal medium vessel occlusions (DMVOs). METHODS: Patients with isolated DMVO stroke from the TOPMOST registry were analyzed with regard to anesthetic strategies (ie, conscious sedation (CS), local (LA) or general anesthesia (GA)). Occlusions were in the P2/P3 or A2-A4 segments of the posterior and anterior cerebral arteries (PCA and ACA), respectively. The primary endpoint was the rate of complete reperfusion (modified Thrombolysis in Cerebral Infarction score 3) and the secondary endpoint was the rate of modified Rankin Scale score 0-1. Safety endpoints were the occurrence of symptomatic intracranial hemorrhage and mortality. RESULTS: Overall, 233 patients were included. The median age was 75 years (range 64-82), 50.6% (n=118) were female, and the baseline National Institutes of Health Stroke Scale score was 8 (IQR 4-12). DMVOs were in the PCA in 59.7% (n=139) and in the ACA in 40.3% (n=94). Thrombectomy was performed under LA±CS (51.1%, n=119) and GA (48.9%, n=114). Complete reperfusion was reached in 73.9% (n=88) and 71.9% (n=82) in the LA±CS and GA groups, respectively (P=0.729). In subgroup analysis, thrombectomy for ACA DMVO favored GA over LA±CS (aOR 3.07, 95% CI 1.24 to 7.57, P=0.015). Rates of secondary and safety outcomes were similar in the LA±CS and GA groups. CONCLUSION: LA±CS compared with GA resulted in similar reperfusion rates after thrombectomy for DMVO stroke of the ACA and PCA. GA may facilitate achieving complete reperfusion in DMVO stroke of the ACA. Safety and functional long-term outcomes were comparable in both groups.

Digital hands-on learning in radiology-design and evaluation of a PACS-based concept for medical students.

BACKGROUND: The reorganization of the medical curriculum has increased the demands on medical didactics. For interdisciplinary fields such as radiology this offers the opportunity to be more visible in clinical medical teaching and to emphasize its integrative role in patient care. We present a novel integrative learning concept based on the notion of PACS (picture archiving and communication system) learning. In the initial phase it was available to students in their final-year internships. METHODS: We designed 100 case vignettes on a designated workstation. Vignettes were prepared in a patient-based format in Aycan PACS (Aycan Medical Systems, NY, USA). The first image of each case included the case description and background information. Students worked through the vignettes independently. Each imaging examination was followed by small quizzes or open questions. Short texts provided additional information on the case, leading to the next examination. The typical case included several imaging modalities (CT, MRI, X­ray, etc.) in diagnosis and follow-up. After processing the cases, the students completed an evaluation form on a five-point Likert scale. RESULTS: Students approved the learning concept in terms of knowledge level, didactic structure, and motivation for self-study. A large proportion of respondents indicated that the new concept had sparked their interest in radiology Almost all students stated that they had benefited from the concept and favored its continuation. CONCLUSION: Our PACS workstation enjoyed high acceptance among students. This underlines the importance of integrative, competence-based teaching models in the medical curriculum. Radiology as a cross-disciplinary discipline is in particular suitable for encouraging students to combine theoretical and practical knowledge and can become a central component in student education through innovative concepts.

A multimodal user interface for touchless control of robotic ultrasound.

PURPOSE: Past research contained the investigation and development of robotic ultrasound. In this context, interfaces which allow for interaction with the robotic system are of paramount importance. Few researchers have addressed the issue of developing non-tactile interaction approaches, although they could be beneficial for maintaining sterility during medical procedures. Interaction could be supported by multimodality, which has the potential to enable intuitive and natural interaction. To assess the feasibility of multimodal interaction for non-tactile control of a co-located robotic ultrasound system, a novel human-robot interaction concept was developed. METHODS: The medical use case of needle-based interventions under hybrid computed tomography and ultrasound imaging was analyzed by interviewing four radiologists. From the resulting workflow, interaction tasks were derived which include human-robot interaction. Based on this, characteristics of a multimodal, touchless human-robot interface were elaborated, suitable interaction modalities were identified, and a corresponding interface was developed, which was thereafter evaluated in a user study with eight participants. RESULTS: The implemented interface includes voice commands, combined with hand gesture control for discrete control and navigation interaction of the robotic US probe, respectively. The interaction concept was evaluated by the users in the form of a quantitative questionnaire with a average usability. Qualitative analysis of interview results revealed user satisfaction with the implemented interaction methods and potential improvements to the system. CONCLUSION: A multimodal, touchless interaction concept for a robotic US for the use case of needle-based procedures in interventional radiology was developed, incorporating combined voice and hand gesture control. Future steps will include the integration of a solution for the missing haptic feedback and the evaluation of its clinical suitability.