Simple Summary The liver maximum capacity test (LiMAx) represents a useful tool to estimate liver function in patients with chronic liver disease. LiMAx results correlate with short-term survival in patients with early stage HCC after transarterial chemo- or radioembolization. Low LiMAx levels might enable the identification of patients with poor hepatic function and decreased short-term survival after treatment. Abstract Transarterial chemoembolization (TACE) and transarterial radioembolization (TARE) are recommended to treat patients with early or intermediate hepatocellular carcinoma (HCC). The liver maximum capacity test (LiMAx) has been supposed to predict the risk of post-interventional liver failure. We investigated the correlation of LiMAx with short-term survival as primary endpoint and the occurrence of adverse events after therapy as secondary endpoint. Our study cohort prospectively included 69 patients receiving TACE (n = 57) or TARE (n = 12). LiMAx test and serological analyses were performed on the day before and 4 weeks after treatment. Hepatic and extrahepatic complications were monitored for 4 weeks. The LiMAx results were not associated with altered liver function and the occurrence of adverse events. The survival rates of patients with BCLC A with LiMAx ≤ 150 μg/kg/h were lower after 30 days (75.0 ± 15.3% vs. 100%, p = 0.011), 90 days (62.5 ± 17.7% vs. 95.8 ± 4.1%, p = 0.011) and 180 days (50.0 ± 17.7% vs. 95.8 ± 4.1%, p = 0.001) compared to those with higher LiMAx levels. The LiMAx test is not suitable to predict liver function abnormalities or the occurrence of complications 4 weeks after therapy but enables the identification of patients with early stage HCC and reduced short-term survival after treatment.

/pdf/the-liver-maximum-capacity-test-limax-is-associated-with-3iealpd2.pdf

The Liver Maximum Capacity Test (LiMAx) Is Associated with Short-Term Survival in Patients with Early Stage HCC Undergoing Transarterial Treatment

INTRODUCTION: The 13C-methacetin breath test (13C-MBT) is a dynamic method for assessing liver function. This proof-of-concept study aimed to investigate the association between 13C-MBT values and outcomes in patients with hepatocellular carcinoma (HCC) undergoing transarterial chemoembolization (TACE). METHODS: A total of 30 patients with HCC were prospectively recruited. Of these, 25 were included in baseline and 20 in longitudinal analysis. 13C-MBTs were performed before the first and second TACE session. Patients were followed for at least 1 year. RESULTS: At baseline, the median 13C-MBT value was 261 μg/kg/hr (interquartile range 159–387). 13C-MBT, albumin-bilirubin, Child-Pugh, and Model for End-Stage Liver Disease scores were associated with overall survival in extended univariable Cox regression (13C-MBT: standardized hazard ratio [sHR] 0.297, 95% confidence interval [CI] 0.111–0.796; albumin-bilirubin score: sHR 4.051, 95% CI 1.813–9.052; Child-Pugh score: sHR 2.616, 95% CI 1.450–4.719; Model for End-Stage Liver Disease score: sHR 2.781, 95% CI 1.356–5.703). Using a cutoff of 140 μg/kg/hr at baseline, 13C-MBT was associated with prognosis (median overall survival 28.5 months [95% CI 0.0–57.1] vs 3.5 months [95% CI 0.0–8.1], log-rank P < 0.001). Regarding prediction of 90-day mortality after second 13C-MBT, the relative change in 13C-MBT values yielded an area under the receiver-operating characteristic curve of 1.000 (P = 0.007). DISCUSSION: Baseline and longitudinal 13C-MBT values predict survival of patients with HCC undergoing TACE. The relative change in 13C-MBT values predicts short-term mortality and may assist in identifying patients who will not benefit from further TACE treatment.

https://doi.org/10.14309/ctg.0000000000000529

13C-Methacetin Breath Test Predicts Survival in Patients With Hepatocellular Carcinoma Undergoing Transarterial Chemoembolization

Local ablation is an important treatment for liver cancer in cases of cirrhosis. Liver failure may occur after ablation, especially in advanced liver diseases. Currently, there is no standardization for peri-interventional risk assessment. The liver maximum capacity test (LiMAx) is used to assess functional liver capacity, but there is a lack of exploration of its use in this context.The aim of this study was to retrospectively evaluate the usefulness of peri-interventional LiMAx measurements in patients with primary or secondary liver cancer who underwent ablation treatment.A LiMAx test was performed at 24 hours pre- and postablation in 49 patients. Blood parameters were collected to determine liver function using MELD and ALBI scores. The results of the LiMAx test were related with these scores and to critical postintervention LiMAx values.LiMAx values correlated strongly with MELD and ALBI scores before the intervention and reflected the change in liver function, as shown by an increase in scores after the intervention. Notably, LiMAx values decreased during the intervention. AUC analysis for patients at risk of reaching a critical liver level after the intervention showed a cutoff value of 186μg/kg/h.The LiMAx test may be a valuable tool in liver ablation for both peri-interventional monitoring of liver function and preintervention risk assessment. 

Peri-interventional LiMAx test for liver ablation – A feasibility study

The authors of the paper carry out a preliminary assessment of the new regulation on clinical trials of medical devices in the context of software based on intelligent algorithms (so-called AI systems). The primary source of law here is the EU Medical Device Regulation (MDR). The study highlights the need to take into account the regulations on artificial intelligence systems when conducting clinical trials. It is justified by their close relationship with the EU provisions on medical devices. The main difficulty in making a legal and ethical assessment of new solutions used in medical devices is the application of various, sometimes divergent, regulations in the field of new technologies and medical law. The study contains preliminary, necessarily balanced and careful, bearing in mind the need to protect patients - research participants (and other people), conclusions on the application of the above provisions in the conduct of clinical trials.

/pdf/badania-kliniczne-wyrobow-medycznych-wykorzystujacych-2opoudtf.pdf

Badania kliniczne wyrobów medycznych wykorzystujących inteligentne algorytmy – wstęp do dyskusji

Stroke is a major cause for death or disability. As imaging based patient stratification improves acute stroke therapy, dynamic susceptibility contrast magnetic resonance imaging (DSC-MRI) is is of major interest to image brain perfusion. However, expert-level perfusion maps require a manual or semi-manual post-processing by a medical expert making the procedure time-consuming and less standardized. Modern machine learning methods such as generative adversarial networks (GANs) have the potential to automate the perfusion map generation on an expert-level without manual validation. We propose a modified pix2pix GAN with a temporal component (temp-pix2pix-GAN) that generates perfusion maps in an end-to-end fashion. We train our model on perfusion maps infused with expert knowledge to encode it into the GANs. The performance was trained and evaluated using the structural similarity index measure (SSIM) on two datasets including acute stroke patients and patients with steno-occlusive disease. Our temp-pix2pix architecture showed high performance on the acute stroke dataset for all perfusion maps (mean SSIM 0.92-0.99) and good performance on data including patients with steno-occlusive disease (mean SSIM 0.84-0.99). While clinical validation is still necessary in future studies, our results mark an important step towards automated expert-level perfusion maps and thus, fast patient stratification. 

Image-to-image generative adversarial networks for synthesizing perfusion parameter maps from DSC-MR images in cerebrovascular disease

BACKGROUND AND OBJECTIVE Liver function is one of the most important parameters for the outcome of transarterial chemoembolization (TACE). The liver maximum capacity (LiMAx) test is a bedside test that provides a real-time option for liver function testing. The objective of this pilot study was to investigate the suitability of the LiMAX test for predicting the TACE outcome. METHODS 20 patients with intermediate-stage hepatocellular carcinoma (HCC) received a LiMAx test 24 h pre and post TACE. In addition, laboratory values were collected to determine liver function and model for endstage liver disease (MELD) scores. The success of TACE was assessed 6 weeks post intervention by morphological imaging tests using modified response evaluation criteria in solid tumors (mRECIST). RESULTS Patients with an objective response (OR = CR + PR) according to mRECIST post TACE had significantly higher values in the pre-interventional LiMAx test than patients with a non-OR (PD or SD) post TACE (r(14) = 0.62, p = 0.01). Higher pre-interventional LiMAx values therefore indicate OR. Patients with a disease control (DC = CR + PR + SD) according to mRECIST post TACE had significantly higher values in the pre-interventional LiMAx test than patients with a non-DC (PD) post TACE (r(14) = 0.65, p = 0.01). Higher pre-interventional LiMAx values therefore indicate DC. The point biserial correlations of LiMAx values pre and post TACE with the outcome OR or DC were descriptively stronger than those of MELD with OR or DC. This suggests that the LiMAx test correlates better with the treatment response than the MELD score. CONCLUSIONS For the first time, we were able to show in our study that patients who are scheduled for TACE could benefit from a LiMAx test to be able to estimate the benefit of TACE. The higher the pre-interventional LiMAx values, the higher the benefit of TACE. On the other hand, laboratory parameters summarized in the form of the MELD score had significantly less descriptive correlation with the TACE outcome.

Prediction of transarterial chemoembolization (TACE) outcome by pre- and postinterventional 13C-methacetin breath test.

BACKGROUND In clinical practice, decisions often must be made rapidly; therefore, automated software is useful for diagnostic support. Perfusion computed tomography and follow-up evaluation of perfusion data are valuable tools for selecting the optimal recanalization therapy in patients with acute ischemic stroke. OBJECTIVE This study aimed to compare commercially available software used to evaluate stroke patients prior to thrombectomy. METHODS The performance of Olea Sphere (OlS) software vs. CT Neuro Perfusion from Syngo (Sy), as well as the electronic Alberta Stroke Program Early Computed Tomography Score (e-ASPECTS) software vs. an experienced radiologist, were compared using descriptive statistics including significance analysis, Spearman's correlation, and the Bland-Altman agreement analysis. For this purpose, 43 data sets of patients with stroke symptoms related to the middle cerebral artery territory were retrospectively post-processed with both tools and analyzed. RESULTS The automatic e-ASPECTS showed high agreement with an expert rater assessment of the ASPECTS. Using OlS and Sy, we compared the parameters for the ischemic core (relative cerebral blood flow), Time to maximum (Tmax) for the penumbra, and the relative mismatch between these two values. Overall, both software tools achieved good agreement, and their respective values correlated well with each other. However, OlS predicted significantly smaller infarct core volumes compared with Sy. CONCLUSIONS Although the absolute values have a certain degree of variation, both software programs have good agreement with each other.

Dynamic perfusion analysis in acute ischemic stroke: A comparative study of two different softwares.

Background Mechanical thrombectomy (MT) is a standard stroke treatment for patients with large vessel occlusions (LVOs). A decisive factor for a successful outcome is, among other things, timely treatment. Objective The objective was to analyze several time points in relation to outcomes and/or surrogate parameters. Furthermore, our data was placed in the context of other clinical trial data. Methods We retrospectively evaluated 133 data sets from patients who underwent MT. The correlation of various time periods with parameters, such as the ASPECTS, NIHSS, mRS, and, particularly, the TICI score, was investigated. Results A correlation was found for both the NIHSS score at discharge and the TICI score with the time periods of arrival and/or start to groin puncture as well as with arrival to the end of the intervention and the duration of the intervention. Conclusions This retrospective study is consistent with large randomized clinical trials investigating stroke management and provides data from daily clinical practice.

Mechanical thrombectomy in ischemic stroke: Parameters affecting the TICI outcome.

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Prediction of transarterial chemoembolization (TACE) outcome by pre- and postinterventional 13C-methacetin breath test.

Dynamic perfusion analysis in acute ischemic stroke: A comparative study of two different softwares.

Mechanical thrombectomy in ischemic stroke: Parameters affecting the TICI outcome.