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Background: Results of a randomised trial showed the safety and efficacy of Gam-COVID-Vac against COVID-19. However, compared to other vaccines used across the globe, the real-world data on the effectiveness of Gam-COVID-Vac, especially against the disease caused by Delta variant of concern, was not available. We aimed to assess the effectiveness of vaccination mainly conducted with Gam-COVID-Vac in St. Petersburg, Russia. Methods: We designed a case-control study to assess the vaccine effectiveness (VE) against lung injury and referral to hospital. Self-reported vaccination status was collected for individuals with confirmed SARS-CoV-2 infection who were referred for initial low-dose computed tomography triage in two outpatient centres in July 3 -- August 9, 2021 in St. Petersburg, Russia. We used logistic regression models to estimate the adjusted (for age, and triage centre) VE for complete (>14 days after the second dose) and partial vaccination (>14 days after the first dose). We estimated the VE against referral for hospital admission, COVID-19-related lung injury assessed with LDCT, and decline in oxygen saturation. Results: In the final analysis, 13,894 patients were included, 1,291 (9.3%) of patients met our criteria for complete vaccination status, and 495 (3.6%) were referred to hospital. In the primary analysis, the adjusted VE against referral to hospital was 81% (95% CI: 68-88) for complete vaccination. The effect of the partial vaccination was not statistically significant. The VE against referral to hospital was more pronounced in women (84%, 95% CI: 66-92) compared to men (76%, 95% CI: 51-88). Vaccine protective effect increased with increasing lung injury categories, from 54% (95% CI: 48-60) against any sign of lung injury to 76% (95% CI: 59-86) against more than 50% lung involvement. A sharp increase was observed in the probability of hospital admission with age for non-vaccinated patients in relation to an almost flat relationship for the completely vaccinated group. Conclusions: COVID-19 vaccination was effective against referral to hospital in patients with symptomatic SARS-CoV-2 infection in St. Petersburg, Russia. This protection is probably mediated through VE against lung injury associated with COVID-19.

Background: Studies of mRNA and vector-based vaccines used in different countries report acceptable levels of effectiveness against SARS-CoV-2 infection caused by the Delta variants of SARS-CoV-2. No studies estimated vaccine effectiveness (VE) of Gam-COVID-Vac and other vaccines used in Russia against symptomatic infection with Delta variant. In this population-based case-control study, we aimed to estimate the effectiveness of the Russian COVID-19 vaccines against symptomatic SARS-CoV-2 during the recent outbreak caused by the Delta VOC in October 2021 in St. Petersburg, Russia. Methods: In a population-based case-control study with density sampling of controls, we acquired information on cases and controls from two independent studies conducted in St. Petersburg. Cases were symptomatic patients with confirmed SARS-CoV-2 (using polymerase chain reaction (PCR) test) referred to low-dose computed tomography (LDCT) triage in two outpatient centres between October 6 and 14, 2021 during the Delta variant outbreak. We recruited the controls during the representative survey of the seroprevalence study conducted during the same period in St. Petersburg using random digit dialling. In the primary analysis, we used logistic regression models to estimate the adjusted (age, gender, and history of confirmed COVID-19) VE against symptomatic SARS-CoV-2 resulted in a referral to triage centre for three vaccines used in Russia: Gam-COVID-Vac, EpiVacCorona, and CoviVac. Findings: We included 1,198 cases and 2,747 controls recruited between the 6th and 14th of October in the final analysis. VE was 58% (95% CI: 50; 64) for Gam-COVID-Vac (Sputnik V), 50% (95% CI: 30; 64) for 1-dose Gam-COVID-Vac (Sputnik V) or Sputnik Light, -40% (95% CI: -191; 33) for EpiVacCorona and 38% (95% CI: 0; 62) for CoviVac. Without adjustment for the history of confirmed COVID-19 VE for all vaccines was lower, except for one-dose Gam-COVID-Vac (Sputnik Light). The adjusted VE was slightly lower in women - 52% (95% CI: 41; 62) than men - 66% (95% CI: 55; 74). It was also higher in younger age. However, in the analysis restricted to participants without a history of confirmed COVID-19, the differences in VE by age group were smaller. Interpretation: In contrast to other Russian vaccines, Gam-COVID-Vac is effective against symptomatic SARS-CoV-2 infection caused by Delta VOC. Effectiveness is likely higher than the estimated 58% due to bias arising from high prevalence of the past COVID-19 in St. Petersburg. Funding: Population-based survey in St. Petersburg was funded by Polymetal International, plc.

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e18289 Background: Venous thromboembolism (VTE) prevention in oncology patients during external beam radiation therapy (RT) in outpatient setting is the challenging question. We performed analysis of our own data. The aim of study is the clear assessment of VTE incidence in these patients Methods: In retrospective analysis 5134 patients' medical records were included (2612 with RT and 2522 with chemotherapy). Inclusion criteria were: RT in outpatient setting and chemotherapy in outpatient setting. Exclusion criteria: combined radiochemotherapy, hospitalzation, central venous catheter, palliative treatment. 487 patients were selected for the final analysis and stratified in 3 groups: group I (n = 165) 3D-conformal RT for brain tumors or brain metastasis; group II (n = 158) RT for body tumors (abdominal, retroabdominal, pelvic, chest, breast); group III (n = 164) was control –brain and body tumors on chemotherapy. Mean fraction numbers were 25 (11 - 32), mean total dose – 52 Gy (22 - 66). VTE assessment based on clinical data, ultrasound examination (US) and chest CT. Statistical analysis was performed by OpenEpi, Version 3 software pack. Results: Deep vein thrombosis (DVT) was detected in 10 cases (6.06%) in group I, 4 cases in group II and 4 case in control group. VTE patients has a different tumors (astrocytomas, brain trunk tumors, skull basis cancer, rectal cancer, breast cancer). 3 patients were available for long-term outcomes assessment (12 months after radiation therapy). During 1-year period we haven’t detected thrombosis recurrence. One patient on 11th follow-up month was exposed with repeated course of RT without any complications. The difference between VTE incidence for group I and group III characterized by statistical significance (p = 0.018). Risk difference for these groups was 5% (p < 0.05). Conclusions: Based on study results we suggest that external beam radiation therapy is potentially an independent risk factor for VTE development even in outpatient settings. High degree of clinical suspicion and aggressive diagnostic work-up in case of suspicion is necessary. In our opinion low molecular weight heparins prevention should be considered at least during active radiation therapy.

Review ArticlePurpose: Operating room management is the serious and complex task for hospital managers and the common approach is to develop relevant standard operational procedures. From patient and staff safety perspective, operating room management should be well-studied and hospital should identify and address any potential risks. Simultaneous usage of different imaging and less-invasive treatment technologies demands strong management control. Materials and Methods:We have formed the multidisciplinary expert panel (surgeons, anesthesiologists, radiologists, healthcare managers etc.) for hybrid theater management standard operational procedure development. On the first stage the general concept of hybrid room design and patient routing was developed. The second stage included the technical details discussion. For patient safety improvement we modified the Surgical Safety Check-list in accordance with potential MRI-related safety challenges and concerns. Results: WHO Surgical Safety Checklist is a simple and easy-to use tool which includes three blocks of question (grouped by the surgery process). We have developed two additional blocks of questions for the intraoperative magnetic resonance investigation. It is very important to have a special detailed routing with a strong control of ferromagnetic devices and anesthesiology care. Conclusion: High-energy MRI (1.5-3.0T) is characterized by potential influence on patient and staff safety in case of hybrid surgery. It is obvious to have a strong managerial control of ferromagnetic devices and anesthesiology care. Surgical Safety Checklist is the validated tool for improving patient safety. Modification and customization of this check-list potentially provides the opportunity for surgery processes improving.

Metastatic pancreatic cancer is characterised by poor prognosis. High toxicity of chemotherapy limits its use in elderly patients with severe comorbidities. Meanwhile, in metastatic disease, local treatment did not show the positive effect on life expectancy. We present a clinical case of a 72-year-old woman with metastatic pancreatic adenocarcinoma tumour, node, metastases (T3N0M1) (according to the seventh TNM classification of the International Union Against Cancer). Chemotherapy led to partial response, but later was stopped due to severe toxicity. Thereafter, consolidating radiosurgical treatment was performed. Dose to pancreatic and liver lesions was 35 Gy in five fractions. After 9 months, only one liver lesion and primary pancreatic tumour, stable in size were determined by MRI. At present time, the patient is alive and in good condition, the disease is stable 50 months after stereotactic body radiation therapy (SBRT). SBRT provides a high level of local control and in combination with systemic treatment can potentially increase survival.

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