-
Journal of Neurointerventional Surgery Jun 2024Mechanical thrombectomy (MT) is the standard of care for acute ischemic stroke (AIS) patients with large vessel occlusion (LVO). The SOFAST study collected clinical...
SOFIA Aspiration System as first-line Technique (SOFAST): a prospective, multicenter study to assess the efficacy and safety of the 6 French SOFIA Flow Plus aspiration catheter for endovascular stroke thrombectomy.
BACKGROUND
Mechanical thrombectomy (MT) is the standard of care for acute ischemic stroke (AIS) patients with large vessel occlusion (LVO). The SOFAST study collected clinical evidence on the safety and efficacy of the 6 French SOFIA Flow Plus aspiration catheter (SOFIA 6F) when used as first-line treatment.
METHODS
This was a prospective, multicenter investigation to assess the safety and efficacy of SOFIA 6F used for first-line aspiration. Anterior circulation LVO stroke patients were enrolled. The primary endpoint was the final modified Thrombolysis in Cerebral Infarction (mTICI)≥2b rate. Secondary endpoints included first-pass and first-line mTICI≥2b rates, times from arteriotomy to clot contact and mTICI≥2b, and 90-day modified Rankin Scale (mRS)≤2. First-line and final mTICI scores were adjudicated by an independent imaging core lab. Safety events were assessed by an independent clinical events adjudicator.
RESULTS
A total of 108 patients were enrolled across 12 centers from July 2020 to June 2022. Median age was 67 years, median National Institutes of Health Stroke Scale (NIHSS) was 15.5, and 56.5% of patients received intravenous thrombolytics. At the end of the procedure, 97.2%, 85.2%, and 55.6% of patients achieved mTICI≥2b, ≥2c, and 3, respectively. With SOFIA 6F first-line aspiration, 87.0%, 79.6%, and 52.8% achieved mTICI≥2b, ≥2c, and 3, respectively. After the first pass, 75.0%, 70.4%, and 50.9% achieved mTICI≥2b, ≥2c, and 3, respectively. Median times from arteriotomy to clot contact and successful revascularization were 12 and 17 min, respectively. At 90 days, 66.7% of patients achieved mRS≤2.
CONCLUSIONS
First-line aspiration with SOFIA 6F is safe and effective with high revascularization rates and short procedure times.
PubMed: 38937082
DOI: 10.1136/jnis-2024-021811 -
Histopathology Jun 2024Lymphovascular space invasion (LVSI) is an important prognostic parameter in endometrial carcinoma (EC) and has gained increasing interest in recent years due to an... (Review)
Review
Lymphovascular space invasion (LVSI) is an important prognostic parameter in endometrial carcinoma (EC) and has gained increasing interest in recent years due to an expanding body of evidence of its independent prognostic value, especially when the presence of LVSI is quantified. A key strength of LVSI as a prognostic factor is that it can be detected on routine microscopic examination, without ancillary tests, and thus can be used in low-resource settings. A weakness, however, is the lack of uniformly applied criteria for assessment and quantification of LVSI, resulting in interobserver variation in diagnosis. This is confounded by artefacts and other morphological features that may mimic LVSI (commonly referred to as pseudo-LVSI). Despite these issues, multiple studies have shown that LVSI is strongly associated with lymph node (LN) metastasis and is an independent risk factor for LN recurrence and distant metastasis. Consequently, the presence of substantial/extensive LVSI has become an important consideration in formulating adjuvant treatment recommendations in patients with EC, and this has been incorporated in the recent International Federation of Gynecology and Obstetrics (FIGO) 2023 staging system. Herein, we review the current literature on LVSI in EC and discuss its role as a prognostic marker, the reproducibility of LVSI assessment and distinction between LVSI and its mimics. We provide illustrations of key diagnostic features and discuss the two-tiered (none/focal versus substantial) system of LVSI classification. This work is intended to provide guidance to practising pathologists and unify the approach towards LVSI assessment in EC.
PubMed: 38937066
DOI: 10.1111/his.15272 -
The Journal of Thoracic and... Jun 2024Shape-sensing robotic-assisted bronchoscopy (ssRAB) is an emerging technology for the sampling of pulmonary lesions. We seek to characterize the ssRAB learning curve at...
OBJECTIVE
Shape-sensing robotic-assisted bronchoscopy (ssRAB) is an emerging technology for the sampling of pulmonary lesions. We seek to characterize the ssRAB learning curve at an academic center.
METHODS
SsRAB procedures performed by 9 proceduralists at a single institution were analyzed. Cumulative sum analyses were performed to examine diagnostic sampling and procedure time over each operator's first 50 cases, with the acceptable yield threshold set to 73%.
RESULTS
During the study period, 442 patients underwent sampling of 551 lesions. Each operator sampled 61 (IQR, 60-63) lesions. Lesion size was 1.90 cm (IQR, 1.33-2.80). The median procedure time for single-target cases decreased from 62 minutes during the first 10 cases to 39 minutes after case 40 (P<0.001). The overall diagnostic yield was 72% (range, 58-83%). Six of 9 operators achieved proficiency over the study period. An aggregated cumulative sum analysis of those who achieved competency demonstrated a steep improvement between lesions 1 and 21 and crossing of the competency threshold by lesion 25. Temporal analysis of yield-related lesion characteristics demonstrated that at approximately lesion 20, more challenging lesions were increasingly targeted, as evidenced by smaller target size, higher rates of unfavorable radial endobronchial ultrasound views and a negative bronchus sign.
CONCLUSIONS
Skills acquisition in ssRAB is variable. Approximately half of proceduralists become facile with the technology within 25 lesions. After the initial learning phase, operators increasingly target lesions with more challenging features. Overall, these findings can inform certification and competency standards and provide new users with expectations related to performance over time.
PubMed: 38936600
DOI: 10.1016/j.jtcvs.2024.06.018 -
Journal of Immunological Methods Jun 2024Acute rejection (AR) undermines the life-extending benefits of kidney transplantation and is diagnosed using the invasive biopsy procedure. T cell-mediated rejection...
INTRODUCTION
Acute rejection (AR) undermines the life-extending benefits of kidney transplantation and is diagnosed using the invasive biopsy procedure. T cell-mediated rejection (TCMR), antibody-mediated rejection (ABMR), or concurrent TCMR + ABMR (Mixed Rejection [MR]) are the three major types of AR. Development of noninvasive biomarkers diagnostic of AR due to any of the three types is a useful addition to the diagnostic armamentarium.
METHODS
We developed customized RT-qPCR assays and measured urinary cell mRNA copy numbers in 145 biopsy-matched urine samples from 126 kidney allograft recipients. We determined whether the urinary cell three-gene signature diagnostic of TCMR (Suthanthiran et al., 2013) discriminates patients with no rejection biopsies (NR, n = 50) from those with ABMR (n = 28) or MR (n = 20) biopsies.
RESULTS
The urinary cell three-gene signature discriminated all three types of rejection biopsies from NR biopsies (P < 0.0001, One-way ANOVA). Dunnett's multiple comparisons test yielded P < 0.0001 for NR vs. TCMR; P < 0.001 for NR vs. ABMR; and P < 0.0001 for NR vs. MR. By bootstrap resampling, optimism-corrected area under the receiver operating characteristic curve (AUC) was 0.749 (bias-corrected 95% confidence interval [CI], 0.638 to 0.840) for NR vs. TCMR (P < 0.0001); 0.780 (95% CI, 0.656 to 0.878) for NR vs. ABMR (P < 0.0001); and 0.857 (95% CI, 0.727 to 0.947) for NR vs. MR (P < 0.0001). All three rejection categories were distinguished from NR biopsies with similar accuracy (all AUC comparisons P > 0.05).
CONCLUSION
The urinary cell three-gene signature score discriminates AR due to TCMR, ABMR or MR from NR biopsies in human kidney allograft recipients.
PubMed: 38936464
DOI: 10.1016/j.jim.2024.113714 -
The Lancet. Oncology Jul 2024The Children's Oncology Group defines intermediate-risk rhabdomyosarcoma as unresected FOXO1 fusion-negative disease arising at an unfavourable site or non-metastatic... (Randomized Controlled Trial)
Randomized Controlled Trial
Addition of temsirolimus to chemotherapy in children, adolescents, and young adults with intermediate-risk rhabdomyosarcoma (ARST1431): a randomised, open-label, phase 3 trial from the Children's Oncology Group.
BACKGROUND
The Children's Oncology Group defines intermediate-risk rhabdomyosarcoma as unresected FOXO1 fusion-negative disease arising at an unfavourable site or non-metastatic FOXO1 fusion-positive disease. Temsirolimus in combination with chemotherapy has shown promising activity in patients with relapsed or refractory rhabdomyosarcoma. We aimed to compare event-free survival in patients with intermediate-risk rhabdomyosarcoma treated with vincristine, actinomycin, and cyclophosphamide alternating with vincristine and irinotecan (VAC/VI) combined with temsirolimus followed by maintenance therapy versus VAC/VI alone with maintenance therapy.
METHODS
ARST1431 was a randomised, open-label, phase 3 trial conducted across 210 institutions in Australia, Canada, New Zealand, and the USA. Eligible patients were those aged 40 years or younger with non-metastatic FOXO1-positive rhabdomyosarcoma or unresected FOXO1-negative rhabdomyosarcoma disease from unfavourable sites. Two other groups of patients were also eligible: those who had FOXO1-negative disease at a favourable site (excluding orbit) that was unresected; and those who were aged younger than 10 years with stage IV FOXO1-negative disease with distant metastases. Eligible patients had to have a Lansky performance status score of 50 or higher if 16 years or younger and a Karnofsky performance status score of 50 or higher if older than 16 years; all patients were previously untreated. Patients were randomised (1:1) in blocks of four and stratified by histology, stage, and group. Patients received intravenous VAC/VI chemotherapy with a cyclophosphamide dose of 1·2 g/m per dose per cycle with or without a reducing dose of intravenous weekly temsirolimus starting at 15 mg/m or 0·5 mg/kg per dose for those who weighed less than 10 kg. The total duration of therapy was 42 weeks followed by 6 months of maintenance therapy with oral cyclophosphamide plus intravenous vinorelbine for all patients. Temsirolimus was withheld during radiotherapy and for 2 weeks before any major surgical procedure. The primary endpoint was 3-year event-free survival. Data were analysed with a revised intention-to-treat approach. The study is registered with ClinicalTrials.gov (NCT02567435) and is complete.
FINDINGS
Between May 23, 2016, and Jan 1, 2022, 325 patients were enrolled. In 297 evaluable patients (148 assigned to VAC/VI alone and 149 assigned to VAC/VI with temsirolimus), the median age was 6·3 years (IQR 3·0-11·3); 33 (11%) patients were aged 18 years or older; 179 (60%) of 297 were male. 113 (77%) of 148 patients were FOXO1 negative in the VAC/VI group, and 108 (73%) of 149 were FOXO1 negative in the VAC/VI with temsirolimus group. With a median follow-up of 3·6 years (IQR 2·8-4·5), 3-year event-free survival did not differ significantly between the two groups (64·8% [95% CI 55·5-74·1] in the VAC/VI group vs 66·8% [57·5-76·2] in the VAC/VI plus temsirolimus group (hazard ratio 0·86 [95% CI 0·58-1·26]; log-rank p=0·44). The most common grade 3-4 adverse events were anaemia (62 events in 60 [41%] of 148 patients in the VAC/VI group vs 89 events in 87 [58%] of 149 patients in the VAC/VI with temsirolimus group), lymphopenia (83 events in 65 [44%] vs 99 events in 71 [48%]), neutropenia (160 events in 99 [67%] vs 164 events in 105 [70%]), and leukopenia (121 events in 86 [58%] vs 132 events in 93 [62%]). There was one treatment-related death in the VAC/VI with temsirolimus group, categorised as not otherwise specified.
INTERPRETATION
Addition of temsirolimus to VAC/VI did not improve event-free survival in patients with intermediate-risk rhabdomyosarcoma defined by their FOXO1 translocation status and clinical factors. Novel biology-based strategies are needed to improve outcomes in this population.
FUNDING
The Children's Oncology Group (supported by the US National Cancer Institute, US National Institutes of Health).
Topics: Humans; Male; Female; Child; Adolescent; Antineoplastic Combined Chemotherapy Protocols; Sirolimus; Rhabdomyosarcoma; Child, Preschool; Vincristine; Young Adult; Cyclophosphamide; Adult; Dactinomycin; Irinotecan; Infant; Progression-Free Survival; Forkhead Box Protein O1
PubMed: 38936378
DOI: 10.1016/S1470-2045(24)00255-9 -
Radiographics : a Review Publication of... Jul 2024In recent years, lung US has evolved from a marginal tool to an integral component of diagnostic chest imaging. Contrast-enhanced US (CEUS) can improve routine... (Review)
Review
In recent years, lung US has evolved from a marginal tool to an integral component of diagnostic chest imaging. Contrast-enhanced US (CEUS) can improve routine gray-scale imaging of the lung and chest, particularly in diagnosis of peripheral lung diseases (PLDs). Although an underused tool in many centers, and despite inherent limitations in evaluation of central lung disease caused by high acoustic impedance between air and soft tissues, lung CEUS has emerged as a valuable tool in diagnosis of PLDs. Owing to the dual arterial supply to the lungs via pulmonary and bronchial (systemic) arteries, different enhancement patterns can be observed at lung CEUS, thereby enabling accurate differential diagnoses in various PLDs. Lung CEUS also assists in identifying patients who may benefit from complementary diagnostic tests, including image-guided percutaneous biopsy. Moreover, lung CEUS-guided percutaneous biopsy has shown feasibility in accessible subpleural lesions, enabling higher histopathologic performance without significantly increasing either imaging time or expenses compared with conventional US. The authors discuss the technique of and basic normal and pathologic findings at conventional lung US, followed by a more detailed discussion of lung CEUS applications, emphasizing specific aspects of pulmonary physiology, basic concepts in lung US enhancement, and the most commonly encountered enhancement patterns of different PLDs. Finally, they discuss the benefits of lung CEUS in planning and guidance of US-guided lung biopsy. RSNA, 2024 Supplemental material is available for this article.
Topics: Humans; Contrast Media; Lung Diseases; Ultrasonography; Diagnosis, Differential; Image Enhancement; Lung; Image-Guided Biopsy
PubMed: 38935548
DOI: 10.1148/rg.230171 -
Acta Neurologica Belgica Jun 2024Two or more National Institutes of Health Stroke Scale (NIHSS) points on each motor items (AL score) have shown good accuracy in predicting large vessel occlusion (LVO)...
BACKGROUND AND AIMS
Two or more National Institutes of Health Stroke Scale (NIHSS) points on each motor items (AL score) have shown good accuracy in predicting large vessel occlusion (LVO) in the prehospital setting of acute ischemic stroke (AIS) care. We aimed to study this score for LVO prediction in our stroke network and predictors of poor outcome (PO) after mechanical thrombectomy (MT).
METHODS
From our Safe Implementation of Thrombolysis in Stroke (SITS) registry including patients receiving reperfusion therapy for AIS, we retrospectively computed the AL score from the admission NIHSS to test the diagnostic accuracy for LVO prediction. Multivariable analysis for independent predictors of LVO on the entire cohort and PO from patients with LVO were performed.
RESULTS
From the 853 patients with AIS (67% LVO), AL was positive in 52%. AL score (Odds ratio [OR] 4.6;95%CI 3.36-6.34), smoking (OR 2.1;95%CI 1.14-3.85), atrial fibrillation (OR 1.6;95%CI1.1-2.4) and younger age (OR 0.98;95%CI0.97-0.99) were independent predictors of LVO. AL score showed 82%/49% positive/negative predictive values with 66% accuracy (64%/72% sensitivity/specificity) for LVO prediction. Age (OR 1.05;95%CI 1.03-1.07), atrial fibrillation (OR 4.85;95%CI 1.5-15.7), diabetes (OR 2.62;95% CI 1.14-6.05), dyslipidemia (OR 2;95% CI 1.04-3.87), AL score (OR 2.68;95% CI 1.45-4.98), longer onset-to-groin time (OR 1.003;95% CI 1.001-1.01), MT procedure (OR 1.01;95%CI 1.003-1.02) general anaesthesia (OR 2.06;95% CI 1.1-3.83) and symptomatic intracranial hemorrhage (OR 12.10;95%CI 3.15-46.44) were independent predictors of PO.
CONCLUSIONS
AL score independently predicted LVO and PO after MT. Patient characteristics and procedural factors determined PO of LVO patients after MT.
PubMed: 38935263
DOI: 10.1007/s13760-024-02591-0 -
The Journal of Hand Surgery Jun 2024Diagnosing the cause of ulnar-sided wrist pain can be difficult in the pediatric and adolescent age group. While frequently used, the diagnostic accuracy of magnetic...
PURPOSE
Diagnosing the cause of ulnar-sided wrist pain can be difficult in the pediatric and adolescent age group. While frequently used, the diagnostic accuracy of magnetic resonance image (MRI), as compared with intraoperative arthroscopic findings, is not well-described in this population. This study aimed to determine concordance rates between magnetic resonance and arthroscopic findings depending on the specific ulnar wrist pathology.
METHODS
A retrospective review was performed to identify pediatric and adolescent patients who underwent operative treatment of ulnar wrist pain between 2004 and 2021. Patients were included in the analysis if they were <18 years of age, complained of ulnar-sided wrist pain, underwent MRI of the affected wrist with an available report interpreted by a consultant radiologist, and had a diagnostic arthroscopy procedure within one year of imaging. Ulnar pathologies analyzed included triangular fibrocartilage (TFCC) tears, ulnotriquetral (UT) ligament tears, lunotriquetral ligament abnormalities, and ulnocarpal impaction.
RESULTS
A total of 40 patients with a mean age of 15-years-old (range 11 to 17) were included in the analysis. Twenty-four were female, and approximately half had their dominant extremity affected. Most had a history of antecedent trauma (n = 34, 85%), but only 15/40 (38%) had a history of fracture. The mean duration of symptoms prior to presentation was six months (standard deviation, 7). The most common etiologies were Palmer 1B TFCC tears (n = 27, 68%) followed by UT split tears (n = 11, 28%). MRI overall demonstrated high specificity (82% to 94%), but low sensitivity (14% to 71%) for ulnar-sided wrist conditions. Accuracy varied between 70% and 83% depending on the specific injury.
CONCLUSION
While MRI is a useful adjunct for determining the cause of ulnar wrist pathologies, findings are often discordant when compared with diagnostic arthroscopy. Surgeons should have a high degree of suspicion for TFCC-related pathology in the setting of positive provocative clinical examination despite negative MRI findings in young patients.
TYPE OF STUDY/LEVEL OF EVIDENCE
Diagnostic IIb.
PubMed: 38934985
DOI: 10.1016/j.jhsa.2024.04.015 -
Neonatology Jun 2024The umbilical venous catheter is a vital access device in neonatal intensive care units for preterm and critically ill infants. Correct positioning is crucial, as...
INTRODUCTION
The umbilical venous catheter is a vital access device in neonatal intensive care units for preterm and critically ill infants. Correct positioning is crucial, as malpositioning can lead to severe complications. According to international guidelines, the position of the umbilical venous catheter tip must be assessed in real time; traditionally, the catheter is visualized with a thoracoabdominal X-ray, but one of the most effective and safest methods is therefore real-time ultrasound.
METHODS
This study compares real-time ultrasound and traditional X-ray methods for assessing umbilical venous catheter tip location in 461 cases. The rate of tip malposition was analyzed retrospectively. The secondary aim was to assess indwelling time of umbilical venous catheters and reasons of removal.
RESULTS
Real-time ultrasound tip location, found to be more reliable and efficient, demonstrated a significantly lower incidence of primary malpositioning compared to X-ray assessments (9.6 vs. 75.9%). The study also highlighted the association of real-time ultrasound with reduced catheter manipulation, fewer radiographs, and higher indwelling times of umbilical venous catheter. The multiple logistic regression showed a high probability of the central safe position of the umbilical venous catheter tip using real-time ultrasound tip location (odds ratio 29.5, 95% confidence interval: 17.4-49.4).
CONCLUSION
The findings support the adoption of real-time ultrasound in clinical settings to enhance umbilical venous catheter placement accuracy and minimize associated risks. A minimal training investment is needed to attain the proficiency to visualize the umbilical venous catheters, offering a substantial advantage in terms of both cost-effectiveness for the procedure and enhanced patient safety.
PubMed: 38934171
DOI: 10.1159/000538905 -
Viruses Jun 2024The serological surveillance of bluetongue in bulk tank milk is an efficient and cost-effective method for the early detection of bluetongue virus incursions in...
The serological surveillance of bluetongue in bulk tank milk is an efficient and cost-effective method for the early detection of bluetongue virus incursions in unvaccinated free areas of the disease. In addition, the availability of standardized and reliable reagents and refined diagnostic procedures with high sensitivity and specificity are essential for surveillance purposes. However, no available reference materials for bluetongue virus serological surveillance in bulk tank milk exist. This study shows the production and characterization of reference material for the implementation of a commercially available bluetongue milk ELISA test in official laboratories, as well as the evaluation of a procedure to increase the sensitivity in samples with low levels of antibodies. This procedure, based on milk protein concentration, allowed us to notably increase the ELISA test's analytical sensitivity, which is useful for milk samples from farms with low within-herd prevalence or pools of bulk tank milk samples. The standardized milk reference material produced here, together with the evaluated procedure to improve analytical sensitivity, could be applied as tools to ensure an accurate diagnosis by official laboratories in bluetongue unvaccinated free areas.
Topics: Animals; Milk; Bluetongue; Bluetongue virus; Enzyme-Linked Immunosorbent Assay; Sensitivity and Specificity; Sheep; Cattle; Milk Proteins; Antibodies, Viral; Serologic Tests; Reference Standards; Female
PubMed: 38932207
DOI: 10.3390/v16060915