Compassionate Use of Tocilizumab for Treatment of SARS-CoV-2 Pneumonia.

BACKGROUND: Preliminary data from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pneumonia patients indicate that a cytokine storm may increase morbidity and mortality. Tocilizumab (anti-IL-6R) is approved by the Food and Drug Administration for treatment of cytokine storm associated with chimeric antigen receptor T-cell therapy. Here we examined compassionate use of tocilizumab in patients with SARS-CoV-2 pneumonia. METHODS: We report on a single-center study of tocilizumab in hospitalized patients with SARS-CoV-2 pneumonia. All patients had confirmed SARS-CoV-2 pneumonia and oxygen saturations <90% on oxygen support with most intubated. We examined clinical and laboratory parameters including oxygen and vasopressor requirements, cytokine profiles, and C-reactive protein (CRP) levels pre- and post-tocilizumab treatment. RESULTS: Twenty-seven SARS-CoV-2 pneumonia patients received one 400 mg dose of tocilizumab. Interleukin (IL)-6 was the predominant cytokine detected at tocilizumab treatment. Significant reductions in temperature and CRP were seen post-tocilizumab. However, 4 patients did not show rapid CRP declines, of whom 3 had poorer outcomes. Oxygen and vasopressor requirements diminished over the first week post-tocilizumab. Twenty-two patients required mechanical ventilation; at last follow-up, 16 were extubated. Adverse events and serious adverse events were minimal, but 2 deaths (7.4%) occurred that were felt unrelated to tocilizumab. CONCLUSIONS: Compared to published reports on the morbidity and mortality associated with SARS-CoV-2, tocilizumab appears to offer benefits in reducing inflammation, oxygen requirements, vasopressor support, and mortality. The rationale for tocilizumab treatment is supported by detection of IL-6 in pathogenic levels in all patients. Additional doses of tocilizumab may be needed for those showing slow declines in CRP. Proof of efficacy awaits randomized, placebo-controlled clinical trials.

Establishing a quality indicator format for endoscopic ultrasound.

AIM: To perform a quality control (QC) review of endoscopic ultrasound (EUS) with emphasis on current consensus established quality indicators. METHODS: A national quality control study of EUS was performed with expanded international comparison. Ten different healthcare institutions in Israel participated in coordination with University of Chicago Medical Center. Each Israeli center provided ten patient reports, compared with twenty reports from University of Chicago Medical Center. Quality indicator forms were prepared with sections to be completed before, during, and after EUS. Physician compliance to all listed indicators was evaluated. Quality indicators were evaluated prior to, during, and after performing EUS. RESULTS: One hundred different EUS procedural reports were analyzed. The mean patient age was 59 years old. Indications for referral were mostly for pancreatic or biliary reasons. QC showed several strongly reported areas, including indications for EUS (97%), anesthesia given (94%), periprocedural pancreatic evaluation (87%), and an overall summary of the EUS examination (82%). Intermediately reported areas included patients' pertinent past medical history (71.7%), evaluation of the biliary tree (63%), and providing medical guidance about potential procedural adverse events, including pancreatitis and bleeding (52%). Half of the reports (50%) did not include a systemic organ evaluation. Other areas, including systematic reporting of screened organs (36%), description of fine needle aspiration (15%), tumor description via tumor-node-metastasis (5%), and listing of adverse events (0%) were largely lacking from procedural documentation. CONCLUSION: Documenting specific EUS quality indicators including listing post-procedural recommendations may improve the quality and efficiency of future EUS examinations and subsequent patient follow-up.

Accuracy and Quality Assessment of EUS-FNA: A Single-Center Large Cohort of Biopsies.

Introduction. Thorough quality control (QC) study with systemic monitoring and evaluation is crucial to optimizing the effectiveness of EUS-FNA. Methods. Retrospective analysis was composed of investigating consecutive patient files that underwent EUS-FNA. QC specifically focused on diagnostic accuracy, impacts on preexisting diagnoses, and case management. Results. 268 patient files were evaluated. EUS-FNA cytology helped establish accurate diagnoses in 92.54% (248/268) of patients. Sensitivity, specificity, PPV, NPV, and accuracy were 83%, 100%, 100%, 91.6%, and 94%, respectively. The most common biopsy site was the pancreas (68%). The most accurate location for EUS-FNA was the esophagus, 13/13 (100%), followed by the pancreas (89.6%). EUS-FNA was least informative for abdominal lymph nodes (70.5%). After FNA and followup, eight false negatives for tumors were found (3%), while 7.5% of samples still lacked a definitive diagnosis. Discussion. QC suggests that the diagnostic accuracy of EUS-FNA might be improved further by (1) taking more FNA passes from suspected lesions, (2) optimizing needle selection (3) having an experienced echo-endoscopist available during the learning curve, and (4) having a cytologist present during the procedure. QC also identified remediable reporting errors. In conclusion, QC study is valuable in identifying weaknesses and thereby augmenting the effectiveness of EUS-FNA.