Predictive Factors For Clinical Outcome Research Articles

No effect of dislocation status at arrival in emergency department on outcome of knee joint dislocations.

Knee dislocation is a rare but severe injury of the lower extremities. The aim of this study was to report on the epidemiology, diagnostics and treatment of such injuries and to identify negative predictors of clinical outcomes. This retrospective analysis included all knee dislocations treated at a Level I Trauma Centre in Germany between 2009 and 2021. Medical records were categorised, collected and analysed in a standardised manner. A follow-up visit 1 year after the injury focused on limitations in knee mobility. A total of 120 knee dislocations were included in the study. 29.3% of patients presented to the emergency department with a dislocated joint, and 17.5% (n = 21) had a neurovascular lesion. At follow-up 12 months after the injury, 65.8% of the patients reported limitations in the range of motion, and 11.7% (n = 14) reported severe limitations in daily activities. Site infections due to surgery occurred in 3.3% of patients. Increased body weight (r = 0.294; p < 0.001 and r = 0.259; p = 0.004), an increased body mass index above 25 kg/m2 (body mass index, r = 0.296; p < 0.001 and r = 0.264; p = 0.004) and deficits in peripheral perfusion as well as sensory and motor function (r = 0.231;p = 0.040 and r = -0.192; p = 0.036) were found to be negative predictive factors for clinical outcome. For posttraumatic neurovascular injury, lack of peripheral perfusion, insufficient sensory and motor function (r = -0.683; p < 0.0001), as well as a higher Schenck grade (r = 0.320; p = 0.037),were identified as independent risk factors. The status of dislocation at the site of the accident and on arrival at the emergency department had no impact on the outcome or neurovascular injury. Knee dislocation is a rare injury with a high rate of severe complications such as neurovascular lesions. In particular, the initial status of neurovascular structures and injury classification showed a relevant negative correlation with the posttraumatic status of nerves and vessels. In particular, patients with these characteristics need close monitoring to prevent negative long-term consequences. Level III.

N-terminal pro atrial natriuretic peptide as a prognostic marker of cardiac resynchronization therapy recipients

BackgroundAlthough the dynamic changes of atrial natriuretic peptide (ANP) expressions in a failing heart are well-documented, the clinical implications of detailed measurements of each ANP molecular form processed from proANP remain unclear. MethodsPatients screening was conducted on patients who were eligible for cardiac resynchronization therapy (CRT) between 2014 and 2019 in our institution. Blood samples and echocardiographic parameters were collected on the day before and six months after implantation. Total ANP, proANP, and N-terminal fragment of proANP (NT-proANP) were examined as predictive biomarkers for cardiac death, left ventricular assist device implantation, and heart failure hospitalization following CRT implantation. ResultsA total of 86 subjects (mean age 70 years, 64 males) who underwent successful CRT implantation were enrolled. Plasma levels of total ANP, proANP, and NT-proANP were not normally distributed [25.8 pM (interquartile range: 11.1–53.1), 2.2 pM (1.0–5.4), and 4.1 nM (2.4–7.1), respectively]. Over a median follow-up of 2.7 years, 31 patients (2 deaths and 29 heart failure hospitalizations) reached the endpoints. Among the different ANP forms, only NT-proANP emerged as an independent predictor of the composite outcome (adjusted odds ratio of 2.542 in those with levels above vs. below the median, 95 % confidence interval 1.151–5.615, p = 0.021). NT-proANP levels were associated with left atrial volume and left diastolic functional parameters and decreased in response to echocardiographic improvements at six months post-implantation (16 ± 44 % decrease in responders vs 18 ± 60 % increase in non-responders, p = 0.005). ConclusionPre-implantation NT-proANP levels could serve as a predictive factor for clinical outcomes in recipients of CRT.

Stereotactic Body Radiotherapy for Spine Oligometastases: A Multicentre Retrospective Study From the Italian Association of Radiotherapy and Clinical Oncology (AIRO)

AimTo evaluate the efficacy of stereotactic body radiotherapy (SBRT) for spine oligometastases. Materials and methodsThis was a multicentre retrospective study of a series of patients who received SBRT for spine oligometastases. The efficacy of SBRT was evaluated in terms of local control as the primary endpoint. Survival outcomes were also analysed to identify predictive factors for clinical outcomes. Toxicity was assessed according to CTCAE v4.0. ResultsBetween March 2018 and July 2022, 183 lesions in 177 patients were analysed. In most patients, SBRT was delivered to a single spine metastasis (82%) for a median total dose of 21 Gy (14–35 Gy) in three fractions (one to five fractions) and a median BED10 = 119 Gy (57.7–152 Gy). Local control rates were 90.3% at 1 year, 84.3% at 2 years and 84.3% at 3 years. Distant progression-free survival rates were 33.1%, 18.5% and 12.4% at 1, 2 and 3 years, with prostate histology (P = 0.023), oligorecurrent disease (P = 0.04) and BED10 > 100 Gy (P = 0.04) found to be predictive on univariate analysis. A further oligometastatic progression was observed in 33 patients (18.6%) treated with a second course of SBRT, reporting at univariate analysis improved overall survival rates (P = 0.01). Polymetastases-free survival rates were 57.8%, 43.4% and 32.4%; concurrent therapy was related to improved outcomes at multivariate analysis (P = 0.009). Overall survival rates were 91.8%, 79.6% and 65.9%, with prostate histology and non-cervical metastases related to better overall survival at multivariate analysis. Pain-flare after SBRT was recorded in 3.3%; five patients underwent surgical decompression after SBRT; there were no grade ≥3 adverse events. ConclusionsIn our experience of only oligometastatic patients, spine SBRT gave excellent results in terms of safety and efficacy. Prostate histology and oligorecurrent disease were predictive factors for improved clinical outcomes; also, patients who experienced a further oligoprogression after SBRT maintained a survival advantage compared with polymetastatic progression. No severe adverse events were reported.

Prevalence and characteristics of ectopic eruption of the first permanent molar and predictive factors for clinical outcome

Background: The primary objective of this study was to assess the occurrence, distribution, and features of ectopic first permanent molars (FPMs), as well as to investigate the clinical outcomes associated with ectopic eruption based on the degree of root resorption observed in primary second molars. Methods: This study was performed retrospectively by examining panoramic radiographs of 7070 patients aged 5 to 12 years. The gender and age of the patients, the number, location, and distribution mode of ectopic FPMs, the resorption degree of the distal roots of primary second molars, and the clinical outcome of ectopic eruption were evaluated. Descriptive statistics and chi-square test were performed on the obtained data using SPSS version 22 (SPSS Inc, Chicago, IL, USA). Results: In 144 of 7070 cases, a total of 221 ectopic permanent first molar teeth were detected (2% prevalence). The mean age of the 144 patients was 8.04 years. Ectopic eruption was most common in patients aged 7–8 years (48.63%), which was statistically significant (P&lt;0.05). Ectopic eruptions were more common in females (58.30%) than males (41.70%; P&lt;0.05). Of the ectopic permanent first molars, 78 (35.30%) were in the mandible, and 143 (64.70%) were in the maxilla. The relationship between the degree of resorption and the type of ectopic eruption was statistically significant (P&lt;0.05). Conclusion: The increase in the severity of root resorption in the primary second molars was a significant predictor for the prognosis of ectopic eruption in the present study. Early diagnosis and treatment of ectopic FPMs are of great importance to preventing premature loss of primary second molars resulting in malocclusion.

Gender and degree of tendon healing are independent predictive factors for clinical outcome in successfully healed rotator cuff tears.

Arthroscopic rotator cuff repair (aRCR) is a commonly performed procedure and has been reported to be a successful treatment. Successful healing has traditionally been considered to be associated with good outcome; however, knowledge on predictive factors affecting final outcome other than tendon healing is limited. This study aims to investigate predictive factors influencing clinical outcome following aRCR in patients with successfully healed tears. This retrospective case-control study was conducted in a single center with 135 patients who had successfully healed tendons based on Sugaya classification (grades I-III) on postoperative magnetic resonance imaging (MRI) scans following aRCR. Clinical outcome measures included Constant-Murley score (CMS), range of motion (ROM), pain score. Various preoperative, intraoperative factors and degree of postoperative tendon healing were assessed to identify independent predictive factors for final clinical outcome. Mean age of patients was 55.9 ± 9.0years and mean follow-up duration was 46.8 ± 14.9months. There were 50 (37%) male and 85 (63.0%) female patients. At final follow-up, mean CMS was 85.7 ± 12.0. Considering mean postoperative CMS and the minimal clinically important difference (MCID) of 10 points for CMS, a cutoff level of 75 points for CMS was set (85-10 = 75) and study population was divided into two study groups (group I, poor outcome, CMS ≤ ;75, and group II, good outcome, CMS > 75). There were 24 (17.8%) patients in group I and 111 (82.2%) patients in group II. Univariate analysis revealed that gender, body mass index (BMI) and degree of tendon healing (Sugaya classification) differed significantly between two groups (p < 0.05). Multivariate logistic regression analysis which was conducted with these variables showed that female gender (odds ratio 3.65) and Sugaya grade III (odds ratio 8.19) were independent predictive factors which were significantly associated with poor outcome (p < 0.05). This study showed that despite achieving a successful healing, considerable amount of patients (17.8%) have ended up with poor outcome. Female gender and degree of tendon healing were identified as independent predictive factors for poor outcome. These data would help surgeons during decision-making, risk assessment and patient counseling. III.

T Cell Subsets are Associated with Clinical Activity and Efficacy of 4.5g Intravenous Glucocorticoid for Moderate-To-Severe Thyroid-Associated Ophthalmopathy

ABSTRACT Background Intravenous glucocorticoid (IVGC) remains the main treatment for moderate-to-severe and active thyroid-associated ophthalmopathy (TAO). However, a substantial number (20–30%) of active moderate-to-severe TAO patients may not respond to IVGC. Some patients may have disease progression despite IVGC treatment or relapse after steroid withdrawal. Objectives To analyze risk factors for clinical activity and predictive factors for clinical outcomes of 4.5 g IVGC therapy in patients with moderate-to-severe TAO. Design and methods Our study was performed in two steps: step 1 involved 110 moderate-to-severe TAO patients and analyzed risk factors for TAO activity; step 2 involved 53 active moderate-to-severe TAO patients from step 1 who were treated with 4.5 g IVGC therapy and analyzed predictive factors for clinical outcomes of IVGC therapy. Multivariate logistic regression analysis was used to identify the independent predictors and establish the predictive model. Results Abnormal TRAb (OR = 4.717; P = 0.019) and the percentage of CD3+CD4+ T cell (OR = 1.092; P = 0.028) were independently associated with the activity of moderate-to-severe TAO patients. The pretreatment CAS-max in both eyes (OR = 7.221; P = 0.013) and the percentage of pretreatment CD3+T cell (OR = 0.718; P = 0.037) were independently associated with therapeutic efficacy. The pretreatment CAS-max in both eyes (OR = 156.53; P = 0.028) and the percentage of post-treatment CD3+T cell (OR = 0.554; P = 0.043) were independently associated with therapeutic efficacy. Besides, multivariable prediction models were established, which were better in the forecasting aspect than single-variable prediction models. Conclusions Based on the findings of this study, we should monitor the peripheral blood T cell subsets for TAO, which could be helpful to timely judge the condition of clinical manifestation and effect of treatment for TAO patients. Multivariable prediction models have been established, which have great significance for clinical work.

Predictive factors for clinical outcomes in Filipino patients with watershed infarction: A single center study.

Watershed infarcts denote ischemic lesions involving the distal territories of two major arteries. For years, hypotheses on its pathophysiological mechanisms have been proposed. Yet, the cause is still widely debated. This study aimed to determine the mechanism of watershed strokes and compare their clinical outcomes to acute ischemic stroke from other causes and predict the factors affecting clinical outcomes in patients with watershed infarcts. This single-center, comparative, six-years retrospective cohort study included patients with a diagnosis of Acute Ischemic Stroke. Patients were classified under watershed group or acute ischemic stroke based on their neuroimaging findings. Stroke mechanisms were determined between groups as well as the factors associated with clinical outcomes in watershed strokes. Among the 424 patients included in the study, large artery atherosclerosis was seen in greater frequency in patients with watershed infarcts regardless of the type (EWIs: n=68, 73% vs IWIs: n=89, 75%). No differences observed in the clinical outcomes between groups. Multiple variable analysis showed that age, female sex, high NIHSS score and presence of underlying malignancy were associated with clinical outcomes. Clinical outcomes between watershed infarcts and acute ischemic strokes were similar. Hemodynamic compromise in the setting of severe stenosis is the underlying mechanism for both types of watershed strokes thus, the goal of treatment is to maintain adequate perfusion. High baseline NIHSS score, increased age, female gender and underlying malignancy were all poor predictors of clinical outcomes in patients with watershed strokes.

Abstract P5-02-49: Efficacy of subsequent-abemaciclib treatment after disease progression on palbociclib combined with endocrine therapy in patients with ER-positive HER2-negative metastatic breast cancer

Abstract Purpose: Currently, CDK4/6i combined with endocrine therapy (ET) has become the standard of care as first- or second-line treatment for estrogen receptor-positive (ER+) human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC). However, at present, there are no guidelines for the selection of appropriate treatments after disease progression on prior CDK4/6i treatment combined with ET. Therefore, this retrospective study aimed to verify the efficacy and evaluate predictive factors of clinical outcomes in the patients with ER+/HER2- MBC during subsequent-abemaciclib treatment after disease progression on prior-palbociclib combined with ET. Methods: In total, 81 patients with ER+/HER2- MBC were treated with palbociclib and ET at our medical center between December 2017 and November 2020. Among them, 25 patients who received subsequent-abemaciclib after disease progression on prior-palbociclib were included. All patients provided informed consent for the indicated treatment. Clinicopathological variables were compared using Fisher’s exact test. The Mann–Whitney U test was used to compare categorical variables. PFS and time to chemotherapy (TTC) were estimated using Kaplan–Meier analysis with 95%CIs. Results: The median age was 69 years, and four women were premenopausal. Stage IV disease occurred in 28.0% (7/25) and visceral metastases were observed in 68.0% (17/25) of the patients. The treatment line of prior-palbociclib was the first-line in 3 (12.0%), second-line in 11 (44.0%), and third- and late-line in 11 patients (44.0%). The median PFS of prior-palbociclib plus ET was 6.3 months (95%CI=5.814–6.786). Subsequent-abemaciclib combined with fulvestrant after disease progression on prior-palbociclib was administered in 64.0% (16/25) of the patients. Median numbers of previous ET and chemotherapy of subsequent-abemaciclib were 2 and 0, respectively. Subsequent-abemaciclib after disease progression on prior-palbociclib resulted in an ORR and clinical benefit rate (CBR) of 16.0% (4/25) and 44.0% (11/25), respectively (Table 1). Kaplan–Meier curve analysis showed that the median PFS was 5.3 months (95%CI=3.082–7.518). Univariate analysis revealed that the best overall response (BOR) ≥PR and progression-free interval (PFI) ≥6 months in prior-palbociclib contributed to better clinical outcomes. Moreover, in multivariate analysis, BOR to prior-palbociclib was the only independent predictive factor for PFS (HR=0.190; 95%CI=0.050–0.722; p=0.015) (Table 2). With regard to grade ≥3 TRAEs in the subsequent-abemaciclib, neutropenia and diarrhea were observed in 16.0% (4/25); appetite loss and fatigue in 12.0% (3/25); leukopenia and anemia in 8.0% (2/25); and thrombocytopenia and liver dysfunction in 4.0% (1/25) of patients. Twelve patients (48.0%) required dose reduction due to TRAEs grade ≥3 in subsequent-abemaciclib. Of them, 10 patients required one dose-level reduction and 2 needed two dose-level reductions. Three patients (12.0%) required dose discontinuation: two had uncontrollable appetite loss and nausea and one had pneumonia. Of the 25 patients, 12 were not administered any prior chemotherapy and the median TTC in those treated with subsequent-abemaciclib was 33.9 months (95%CI=11.334–56.136). Next-line treatment after disease progression on subsequent-abemaciclib in the patients who were not administered prior chemotherapy was performed in 2 (8.0%) who were treated with ET and in 12 (48.0%) who were treated with chemotherapy (1 taxane-based, 7 eribulin, and 4 oral 5-fluorouracil). The median PFS in patients treated with chemotherapy after disease progression on subsequent-abemaciclib treatment was 6.2 months (95%CI=3.484–8.916). Table 1. Best overall response rate in patients with ER+/HER- MBC who were treated with subsequent-abemaciclib after disease progression on prior-palbociclib Table 2. Univariate and multivariate analyses of the progression-free survival in patients with ER+/HER2- MBC treated with subsequent-abemaciclib after progression on prior-palbociclib Citation Format: Hirohito Seki, Taketo Nakai, Ken Shimizu. Efficacy of subsequent-abemaciclib treatment after disease progression on palbociclib combined with endocrine therapy in patients with ER-positive HER2-negative metastatic breast cancer [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P5-02-49.

Relationships between Clinical Status and Gait Parameters in Ankylosing Spondylitis.

This study aimed to identify the relationship between gait parameters and health-related quality of life (HRQOL) in patients with ankylosing spondylitis (AS). The study group comprised 134 patients with AS and 124 patients were enrolled as controls. All study participants underwent instrumented gait analysis and completed clinical questionnaires. The kinematic parameters of gait were walking speed, step length, cadence, stance phase, single support, double support, phase coordination index (PCI), and gait asymmetry (GA). For each patient, a visual analog scale (VAS; 0-10) score was used to assess back pain, 36-item short form survey (SF-36) questionnaire was administered to evaluate the HRQOL, and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was calculated. Using kinematic parameters and questionnaires, statistical analyses were done to investigate significant differences between the groups. Relationship of gait kinematic data and questionnaires of clinical outcome was also evaluated. Among the 134 patients with AS, 34 were women and 100 were men. In the control group, 26 were women and 98 were men. The patients with AS and control group patients had significant differences in terms of walking speed, step length, single support, PCI, and GA. However, such differences were not observed in cadence, stance phase, and double support (p > 0.05). In correlation analyses, gait kinematic parameters and clinical outcomes were significantly related with each other. In multiple regression analysis performed to identify predictive factors for clinical outcome, walking speed was found to predict VAS, and walking speed and step length were found to predict the BASDAI and SF-36 scores. Patients with and without AS had significant differences in the gait parameters. Correlation analysis showed significant correlation between the gait kinematic data and clinical outcomes. In particular, walking speed and step length successfully predicted clinical outcomes in patients with AS.

Prevalence and predictive factors for clinical outcomes of isolated functional tricuspid regurgitation

BackgroundA substantial number of patients have functional tricuspid regurgitation (TR).Isolated functional TR has been undertreated and may be a next target for transcatheter intervention. However, the prevalence, patient characteristics, and predictive factors for prognosis remain unclear. MethodsFrom patients in our echocardiographic database (N = 64,242), we extracted those with severe TR and examined prognosis according to etiologies of TR. Thereafter, we focused on two types of isolated functional TR; progressive TR after left-sided valve surgery (postoperative TR) and TR associated with annular dilatation (atrial TR). Composite adverse events were defined as all-cause death or hospitalization for heart failure (HF). ResultsOf 1001 patients with severe TR (median age, 77 years; female, 58 %), 71 (7 %) patients were classified as postoperative TR, and 149 (15 %) as atrial TR. During the follow-up period (median, 1.6 years), 30 composite adverse events were observed (postoperative TR, n = 14; atrial TR, n = 16). Composite adverse events were less frequent in these two types of functional TR than TR of other etiologies. Multivariate analysis adjusted for age and sex showed that a history of hospitalization for HF, history of cardiac surgery >2 times, loop diuretics, estimated glomerular filtration rate, blood urea nitrogen, hemoglobin, platelet level, left ventricular ejection fraction, and right ventricular dimension were associated with clinical adverse events (p < 0.05), while B-type natriuretic peptide level was not. ConclusionsA considerable number of patients had isolated functional TR. Extracardiac factors such as renal function, hemoglobin and platelet are important in determining clinical outcomes.

Endovascular treatment in patients with coma that developed secondary to acute basilar artery occlusion.

This study aimed to evaluate the efficacy of endovascular treatment (EVT) in patients with secondary coma following acute basilar artery occlusion (comatose patients) and to identify the impact of the Glasgow Coma Scale (GCS) score on medical decisions. Patients from the Endovascular Treatment for Acute Basilar Artery Occlusion study were divided into comatose and noncomatose cohorts. The primary outcome was favorable functional independence (modified Rankin Scale [mRS] scores 0-3). The safety outcome was 90-day mortality. Subgroup analysis was performed to identify populations best suited for EVT. Multivariate logistic regression was used to identify independent predictive factors of clinical outcomes. Comatose patients who underwent EVT had more favorable functional outcomes and lower mortality compared with those who underwent standard medical treatment (functional outcomes: 15.98% vs 4.17%; mortality: 62.72% vs 82.29%). Moreover, EVT was associated with better outcomes in the cohort with GCS scores of 6-8 (mRS scores 0-3, 25.33% and mortality, 41.33%) than in the cohort with GCS scores of 3-5. Multivariate analysis indicated that EVT was an independent factor for favorable functional outcomes (adjusted OR 8.921, 95% CI 2.330-34.158) and mortality (adjusted OR 0.189, 95% CI 0.092-0.411) in comatose patients. The initial GCS score was an independent factor for favorable functional outcomes (adjusted OR 1.402, 95% CI 1.115-1.763) and mortality (adjusted OR 0.613, 95% CI 0.499-0.752) in comatose patients with EVT. EVT significantly improved the prognosis of comatose patients, and patients with GCS scores of 6-8 were found to benefit more from EVT than those with GCS scores of 3-5. The initial GCS score was an independent predictive factor for prognosis in comatose patients.

Predictive Factors for Clinical Outcome After Direct Mechanical Thrombectomy for Anterior Circulation Large Vessel Occlusion Within 4.5 h.

BackgroundRecent trials including DIRECT-MT, DEVT, and SKIP have found that direct mechanical thrombectomy (MT) is equally effective as the combination of MT and intravenous thrombolysis. However, the results of the other trials, namely MR-CLEAN NO-IV and the SWIFT-DIRECT trial have failed to confirm the non-inferiority of direct MT vs. the combination therapy.AimWe aimed to identify prognostic factors of direct MT for anterior circulation large vessel occlusion within 4.5 h.Materials and MethodsData from January 2018 to January 2022 were retrospectively collected and analyzed. Adult patients with confirmed anterior circulation large vessel occlusion within 4.5 h of onset with baseline NIHSS of ≥6 and baseline ASPECTS of ≥6 treated using direct MT within 6 h were recruited.ResultsA total of 140 patients were enrolled in the study with a median age of 65.5 years [interquartile range (IQR), 59–76.5], median baseline NIHSS of 13.5 (IQR, 11–16), and median baseline ASPECTS of 8 (IQR, 7–8). Direct MT was feasible in all patients (100%). Successful reperfusion (mTICI 2b-3) was achieved in 124/140 patients (88.6%) with a low rate of complications (8/140, 5.7%). Any type of intracranial hemorrhage (ICH) and symptomatic ICH occurred in 44/140 (31.4%) and 5/140 (3.6%), respectively. Overall, a good outcome (mRS 0–2) was achieved in 93/140 (66.4%), and the mortality rate was 9.3% (13/140 patients). Using multivariate analysis, lower age [odds ratio (OR), 0.96; 95% CI, 0.92–1.00; P = 0.05], low baseline NIHSS (OR, 0.82; 95% CI, 0.74–0.92; P = 0.00), and absence of ICH (OR, 0.29; 95% CI, 0.10–0.81; P = 0.02) were independently associated with favorable outcome. Independent predictors of mortality were baseline NIHSS (OR, 1.21; 95% CI, 1.01–1.46; P = 0.04), successful reperfusion (OR, 0.02; 95% CI, 0.00–0.58; P = 0.02), and ICH (OR, 0.12; 95% CI, 0.02–0.75; P = 0.02). Further analysis showed that the median mRS at 90 days was significantly better in the MCA occlusion group compared to the ICA plus M1 occlusion group [1 (IQR 0–3) vs. 2 (IQR 1–4); P = 0.05].ConclusionsOur findings suggest that direct thrombectomy may be an adequate clinical option for younger patients (≤70) experiencing proximal middle artery occlusion within 4.5 h and who have low baseline NIHSS (≤14).

Living-Donor Liver Transplantation for Hepatocellular Carcinoma: Impact of the MELD Score and Predictive Value of NLR on Survival.

Background: Patients with hepatocellular carcinoma (HCC) tend to be referred for liver transplantation (LT) at an early stage of cirrhosis, with lower pre-LT Model of End-Stage Liver Disease (MELD) scores. We investigated the impact of high MELD scores on post-LT outcomes in patients with HCC and validated the prognostic significance of the neutrophil-to-lymphocyte ratio (NLR). Patients and Method: This retrospective single-center cohort study enrolled 230 patients with HCC who underwent LDLT from 2004–2019 in our institute. We defined a high MELD score as ≥20. Results: The MELD < 20 and MELD ≥ 20 groups comprised 205 and 25 cases, respectively. Although there was no significant difference in disease-free survival between the two groups (p = 0.629), the incidence of septic shock (p = 0.019) was significantly higher in the high MELD group. The one-, three-, and five-year overall survival rates were not significantly different between the two groups (p = 0.056). In univariate analysis, a high pre-LT NLR was associated with poorer survival in the high MELD group (p = 0.029, hazard ratio [HR]: 1.07, 90% confidence interval [CI]: 1.02–1.13). NLR cut-off values of ≥10.7 and <10.7 were predictive of mortality, with an AUC of 0.705 (90% CI: 0.532–0.879). The one-, three-, and five-year post-LT survival rates were significantly higher among the recipients with an NLR < 10.7 than those with an NLR ≥ 10.7 (p = 0.005). Conclusions: Pre-LT MELD score ≥ 20 was associated with a higher risk of developing post-LT septic shock and mortality. The pre-LT serum NLR is a useful predictive factor for clinical outcomes in patients with HCC with high MELD scores.

Predictive factors of clinical outcomes in patients with COVID-19 treated with tocilizumab: A monocentric retrospective analysis.

The aim of this retrospective observational study is to analyse clinical, serological and radiological predictors of outcome in patients with COVID-19 pneumonia treated with tocilizumab, providing clinical guidance to its use in real-life. This is a retrospective, monocentric observational cohort study. All consecutive patients hospitalized between February the 11th and April 14th 2020 for severe COVID-19 pneumonia at Reggio Emilia AUSL and treated with tocilizumab were enrolled. The patient's clinical status was recorded every day using the WHO ordinal scale for clinical improvement. Response to treatment was defined as an improvement of one point (from the status at the beginning of tocilizumab treatment) during the follow-up on this scale. Bivariate association of main patients' characteristics with outcomes was explored by descriptive statistics and Fisher or Kruskal Wallis tests (respectively for qualitative or quantitative variables). Each clinically significant predictor was checked by a loglikelihood ratio test (in univariate logistic models for each of the considered outcomes) against the null model. A total of 173 patients were included. Only hypertension, the use of angiotensin-converting enzyme inhibitors, PaO2/FiO2, respiratory rate and C-reactive protein were selected for the multivariate analysis. In the multivariable model, none of them was significantly associated with response. Evaluating a large number of clinical variables, our study did not find new predictors of outcome in COVID19 patients treated with tocilizumab. Further studies are needed to investigate the use of tocilizumab in COVID-19 and to better identify clinical phenotypes which could benefit from this treatment.

SBRT for elderly oligometastatic patients as a feasible, safe and effective treatment opportunity.

The constantly increasing life expectancy is raising the issue of treating oncological older patients, who were traditionally candidates to best supportive care or palliative treatments. Several literature data support SBRT in the treatment of the oligometastatic patient as a potentially curable therapeutic option. However, data on older patients are lacking. This study presents the outcomes of a cohort of 61 oligometastatic patients over the age of 80years who received SBRT, that was proposed to all patients with a minimum Karnofsky Performance Status ≥ 70 and a life expectancy of at least 6months, with up to five oligometastatic lesions. Radiotherapy was delivered in 3-10 fractions with VMAT-IGRT technique. Toxicity was retrospectively collected according to CTCAE v4.0. Data were retrospectively collected and analyzed. Univariate and multivariate analysis were performed for assessing any potential predictive factor for clinical outcomes. A total of 90 oligometastases were treated in 61 patients with median age 82years (range, 80-90). The most frequent histology was colorectal cancer (27% of cases). Median follow-up was 20months (range, 2-63). Local control rates at 1- and 2-years were 98.8% and 88.2%, with colorectal histology being associated with worse LC rates (p = 0.014) at univariate analysis. Progression-free survival rates at 1- and 2-years were 48.6% and 30.5%. Oligorecurrent lesions and single oligometastases were associated with better PFS rates (respectively, p = 0.04 and p = 0.011). Overall survival rates were 75% and 60.5%, polymetastatic spread being predictive of worse survival outcomes at multivariate analysis (p = 0.012). No G2 or higher adverse events were recorded. Our study supports the role of SBRT for the treatment of elderly oligometastatic patients, highlighting the possibility to further explore this therapeutic option in the management of older oncological patients.

Clinical Evaluation of the Efficacy and Safety of Co-Administration of Wuzhi Capsule and Tacrolimus in Adult Chinese Patients with Myasthenia Gravis.

BackgroundTacrolimus has been recommended as an effective immunosuppressant for patients with myasthenia gravis (MG), while the high price, variable bioavailability, and narrow therapeutic window restrict its clinical application. Wuzhi capsule (WZC) could improve tacrolimus blood concentration by inhibiting the metabolism of cytochrome P450 3A (CYP3A) and P-glycoprotein (P-gp). There are few studies focused on the coadministration of WZC and tacrolimus in autoimmune diseases. This study was aimed at quantifying the efficacy and safety of coadministration of WZC and tacrolimus in adult Chinese patients with MG.MethodsIn this retrospective study, 122 patients with MG on tacrolimus were enrolled. The initial tacrolimus dose was 2 mg/d. Patients with standard initial tacrolimus concentration were classified into group A (standard-dose group). Those failed to reach target concentration were divided into group B (high-dose group) and group C (co-administering WZC group), according to treatment adjustment of increasing tacrolimus dose and co-administration of WZC, respectively. A logistic analysis was used to identify factors associated with clinical outcome. Adverse drug reactions (ADRs) were recorded for safety analysis.ResultsThe tacrolimus concentration after coadministration of WZC was remarkably increased. It was higher compared with simply increasing the tacrolimus dose (p<0.001). The multivariate logistic analysis indicated that the baseline quantitative MG score was a predictive factor for clinical outcomes (OR=0.189; 95% CI 0.082–0.436; p<0.001). Fourteen patients (11.5%) reported ADRs after tacrolimus therapy. ADRs incidence was not related to WZC coadministration.ConclusionThe coadministration of WZC and tacrolimus can substantially elevate the tacrolimus concentration. It is a safe and economic treatment for adult Chinese patients with MG. Patients with a worse disease condition tend to present a better clinical outcome after tacrolimus therapy.

Mechanical thrombectomy for acute ischemic stroke in the posterior circulation: assessment of efficacy and outcome and identification of prognostic factors.

Mechanical thrombectomy (MT) is well-established in the treatment of acute ischemic anterior circulation stroke. However, there is no evidence from randomized trials or meta-analyses that MT is safe and effective in the treatment of patients with acute ischemic posterior circulation stroke (PCS). To evaluate the clinical and procedural factors associated with recanalization and outcome of patients with PCS treated with MT. Forty-three patients with PCS (median age 73 years) who underwent treatment with MT were included. Data including demographics, baseline stroke severity, radiological imaging, procedure and post-procedure complications were documented. Clinical outcome was evaluated using the modified Rankin Scale (mRS). The patients were classified into two groups based on clinical outcome (favorable vs. unfavorable mRS after 90 days). Median baseline National Institute of Health Stroke Scale (NIHSS) was 17. Twenty patients were eligible for intravenous thrombolysis and received recombinant tissue plasminogen activator before MT. Successful recanalization was observed in 88.4% of patients. After 90 days, favorable outcome (defined as mRS 0-2) was achieved in 26 patients; six patients had an unfavorable outcome (mRs >2). Final mortality rate was 25.5%. Baseline NIHSS, onset to reperfusion time, procedure duration, and successful recanalization had a statistically significant association with outcome. Failed recanalization and occurrence of intracranial hemorrhage were found to be associated with a higher mortality rate. MT is feasible and effective method in treatment of PCS. Baseline NIHSS and onset to reperfusion time were found to be independent predictive factors of clinical outcome.

Therapeutic Strategy of Percutaneous Transforaminal Endoscopic Decompression for Stenosis Associated With Adult Degenerative Scoliosis

Study Design:A retrospective study.Objective:To investigate the effects of percutaneous transforaminal endoscopic decompression (PTED) for lumbar stenosis associated with adult degenerative scoliosis and to analyze the correlation between preoperative radiological parameters and postoperative surgical outcomes.Methods:Two years of retrospective data was collected from 46 patients with lumbar stenosis associated with adult degenerative scoliosis who underwent PTED. The visual analog scale (VAS), Oswestry Disability Index, and modified MacNab criteria were used to evaluate the clinical outcomes. Multiple linear regression analysis was used to analyze the correlation between radiological parameters and surgical outcomes.Results:The mean age of the 33 female and 13 male patients was 73.5 ± 8.1 years. The mean follow-up was 27.6 ± 3.5 months (range from 24 to 36). The average coronal Cobb angle was 24.5 ± 8.2°. There were better outcomes of the VAS for leg pain and Oswestry Disability Index after surgery. Based on the MacNab criteria, excellent or good outcomes were noted in 84.78% of patients. Multiple linear regression analysis showed that Cobb angle and lateral olisthy may be the predictors for low back pain.Conclusion:Transforaminal endoscopic surgery may be an effective and safe method for geriatric patients with lumbar stenosis associated with degenerative scoliosis. The predictive factors of clinical outcomes were severe Cobb angle and high degree lateral subluxation. Transforaminal endoscopic surgery may not be recommended for patients with Cobb angle larger than 30° combined with lateral subluxation.

Depth of Response and Early Tumor Shrinkage for Predicting Clinical Outcomes in HER2-Positive Metastatic Breast Cancer Treated with Trastuzumab.

BackgroundTo evaluate whether the depth of response (DepRe) and early tumor shrinkage (ETS) are predictive factors of clinical outcomes in HER2-positive metastatic breast cancer (mBC) patients treated with trastuzumab.MethodsWe performed a retrospective study of 100 HER2-positive mBC patients who received trastuzumab combined with chemotherapy as first-line treatment. ETS and DepRe were calculated. We employed Youden’s index to determine the optimal cutoff value of ETS and DepRe for predicting progression-free survival (PFS) and overall survival (OS). We used Kaplan–Meier analysis, Log-rank tests, and Cox proportional hazards regression models to evaluate the impacts of ETS and DepRe on clinical outcomes.ResultsThe optimal cutoff values were 30% for ETS and 40% for DepRe; ETS and DepRe were observed in 51.0% (51/100) and in 56.0% (56/100) of patients, respectively. Both ETS≥30% and DepRe≥40% were significant tumor-size metrics for predicting PFS (ETS: median 1.43 vs 0.69 years, hazard ratio [HR] = 0.384; 95% confidence interval [CI]: 0.245 to 0.601; P=0.000030; DepRe: median 1.43 vs 0.59 years, HR = 0.390; 95% CI: 0.250 to 0.609; P=0.0000034), but only DepRe≥40% was a significant predictor for OS (median 4.02 vs 3.07 years, HR = 0.484; 95% CI: 0.255 to 0.919; P = 0.027). Multivariate analyses also identified DepRe as an independent prognostic factor for PFS (HR = 0.52; 95% CI: 0.29 to 0.93; P = 0.028) and OS (HR=0.37; 95% CI:0.15 to 0.90; P = 0.029).ConclusionETS≥30% and DepRe≥40% were significant predictors of better clinical outcomes in mBC patients treated with first-line trastuzumab-based chemotherapy. Further validation in prospective trials with larger patient populations is needed.

Robot-assisted simple prostatectomy versus open simple prostatectomy: a single-center comparison

PurposeOpen simple prostatectomy (OSP) is a standard surgical technique for patients with benign prostatic hyperplasia with prostate size larger than 80 ml. As a minimally invasive approach, robot-assisted simple prostatectomy (RASP) emerged as a feasible surgical alternative. Currently, there are no definite recommendations for the standard use of RASP. Therefore, we aimed at investigating various clinical outcomes comparing RASP with OSP.MethodsIn this retrospective single-center study, we evaluated clinical data from 103 RASP and 31 OSP patients. Both cohorts were compared regarding different clinical characteristics with and without propensity score matching. To detect independent predictive factors for clinical outcomes, multivariate logistic regression analysis was performed.ResultsRobot-assisted simple prostatectomy patients demonstrated a lower estimated blood loss and need for postoperative blood transfusions as well as less postoperative complications. OSP had a shorter operative time (125 min vs. 182 min) longer hospital stay (11 days vs. 9 days) and longer time to catheter removal (8 days vs. 6 days). In the multivariate analysis, RASP was identified as an independent predictor for longer operative time, lower estimated blood loss, shorter length of hospital stay, shorter time to catheter removal, less postoperative complications and blood transfusions.ConclusionRobot-assisted simple prostatectomy is a safe alternative to OSP with less perioperative and postoperative morbidity. Whether OSP (shorter operative time) or RASP (shorter length of hospital stay) has a more favorable economic impact depends on the particular conditions of different health care systems. Further prospective comparative research is warranted to define the value of RASP in the current surgical management of benign prostatic hyperplasia.