key: cord-0876641-6c0ssk07 authors: Andrei, Stefan; Isac, Sebastian; Jelea, Diana; Martac, Cristina; Stefan, Mihai-Gabriel; Cotorogea-Simion, Mihail; Buzatu, Cristina Georgiana S.; Ingustu, Daiana; Abdulkareem, Imam; Vasilescu, Catalin; Filipescu, Daniela; Droc, Gabriela title: COVID-19 Pandemic Was Associated with Lower Activity but Not Higher Perioperative Mortality in a Large Eastern European Center date: 2022-03-30 journal: Med Sci Monit DOI: 10.12659/msm.935809 sha: 8e7145aa8fb9be2c4d5261d9ac748c8d720a2684 doc_id: 876641 cord_uid: 6c0ssk07 BACKGROUND: Surges of critically ill patients can overwhelm hospitals during pandemic waves and disrupt essential surgical activity. This study aimed to determine whether hospital mortality increased during the COVID-19 pandemic and during pandemic waves. MATERIAL/METHODS: This was a retrospective analysis of a prospective, observational, epidemiological database. All patients who underwent surgery from January 1 to December 31, 2020, were included in the analysis. The setting was a large Eastern European Surgical Center referral center of liver transplant and liver surgery, a major center of abdominal surgery. RESULTS: A total of 1078 patients were analyzed, and this number corresponded to a reduction of surgical activity by 30% during the year 2020 compared with 2019. Despite an increase in surgery complexity during the pandemic, perioperative mortality was not different, and this was maintained during the pandemic wave. The pandemic (OR 1.45 [0.65–3.22], P=0.365) and the wave period (OR 0.897 [0.4–2], P=0.79) were not associated with hospital mortality in univariate analysis. In the multivariate model analysis, only the American Society of Anesthesiology (ASA) score (OR 5.815 [2.9–11.67], P<0.0001), emergency surgery (OR 5.066 [2.24–11.48], P<0.0001), and need for surgical reintervention (OR 5.195 [1.78–15.16], P=0.003) were associated with hospital mortality. CONCLUSIONS: Despite considerable challenges, in this large retrospective cohort, perioperative mortality was similar to that of pre-pandemic practice. Efforts should be made to optimize personnel issues, while maintaining COVID-19-free surgical pathways, to adequately address patients’ surgical needs during the following waves of the pandemic. Usual surgical activity was disrupted in the context of the new coronavirus (COVID-19) pandemic [1] , particularly during the sudden surges in hospitalized patients associated with pandemic waves. These surges were expected to have a significant impact on adult elective surgeries in many countries, thus increasing perioperative mortality and the complication rate [2] . Each national health authority organized and made decisions according to local specificities, considering the COVID-19 pandemic evolution, healthcare characteristics, and other challenges [3] [4] [5] . Different recommendations concerning the postponing and cancelling of elective surgeries were proposed. At a national level in Romania, owing to anticipated limitations in surge-response capacity, decisions were initially made to limit the number of non-urgent surgical interventions to free Intensive Care Unit (ICU) beds for patients with COVID-19 in need of ventilatory support or other specific therapies [6] . Later, hospitals were required to keep a dedicated ward and ICU beds for patients with COVID-19 as a back-up, while entire hospitals (mainly, but not limited to, those specializing in infectious diseases and pulmonology) were converted to COVID-19 facilities. The impact of the pandemic on patient chronic pathologies and delayed surgeries has still not been very well evaluated, especially in the context of heterogenous measures and diversity of local conditions. From the anesthesiologists' perspective, the Romanian healthcare system has a history of chronic personnel deficits [7] ; it was confronted with several challenges during the first year of the COVID-19 pandemic. The anesthesiologists are also intensive care medicine physicians and are responsible for ICU management and care, like those in various countries worldwide. Thus, the surges of critically ill patients in the successive waves of the pandemic posed challenges for staffing the operating rooms, particularly for non-urgent surgery, which were not fully addressed by emerging guidelines based on accumulating experience in other countries [8] . Medical staff volunteered or were temporarily transferred to other highly understaffed provincial hospitals due to new legislation allowing for relocation of physicians and nurses in areas under severe pressure caused by case overload [9] . Local personnel SARS-CoV-2 outbreaks required home-isolation or even hospitalization of staff members, creating further management difficulties [10] . Also, infrastructure particularities in the local ICUs caused another struggle, namely making patient isolation due to non-SARS-CoV-2 infections very difficult in a local environment with a high prevalence of antimicrobial resistance [11] . Dedicated personnel were hard to summon, which could have sometimes led to suboptimal bed use. This had an impact on surgical activity and, despite workload increase, owing to medical and administrative reasons, the chronic lack of medical staff was accentuated. The main objective of this study was to evaluate the impact of the pandemic on perioperative mortality. The secondary objectives were (i) to evaluate the impact of wave periods on perioperative mortality; and (ii) to describe the patient profiles during the first pandemic year. We hypothesized that diminished availability of medical personnel, restrictive surgical planning, and a lower number of available surgical ICU beds would be reflected in a higher incidence of perioperative mortality and surgical complications during the pandemic. The study was a retrospective analysis of a prospective, observational, epidemiological database and was conducted in a single tertiary, university-affiliated national center, the main national center of liver transplant and liver surgery and a major center for abdominal surgery. The timeline of the COVID-19 pandemic in Romania is illustrated in Figure 1 . The pandemic was declared by the governmental authorities on March 16, 2020, when a state of emergency was issued with consequent restrictions, which had an impact on hospital activity [12] . This date was used to divide patients in our study into 2 groups by period: pandemic and non-pandemic. Furthermore, a surge in new cases with concomitant impact on ICU bed availability was registered from October 2020 until the end of 2020 (Figure 1) . The patients undergoing surgery between October 1 and December 31, 2020, were treated in the context of the SARS-CoV-2 wave in data analysis. A comprehensive history of the epidemiology and legal framework of the pandemic in Romania is provided in Supplementary Table 1. All patients who underwent surgery from January 1, 2020, to December 31, 2020, in our department were included. The preoperative demographical characteristics (age, sex, American Society of Anesthesiology [ASA] score) and the intraoperative data (type and length of surgery, emergency status, cancer surgery, intraoperative packed red blood cell [PRBC] transfusion) for each patient were entered in an electronic database by the anesthetist at the end of surgery. Hospital mortality was recorded using electronic records. Data were collected in a Microsoft Excel database and analyzed using SPSS (IBM SPSS Statistics for Windows, version 21.0; IBM Corp, Armonk, NY, USA). A 2-sided P<0.05 was considered, a priori, statistically significant. Descriptive statistics were expressed as mean±standard deviation or as median with interquartile range (IQR; 25-75%), as appropriate. Normal distribution for continuous variables was evaluated by histograms and by the Kolmogorov-Smirnoff test. The t test or Mann-Whitney test were used, as appropriate, for comparisons of continuous variables. The chi-squared test was used to compare categorical variables. We firstly determined the variables associated with 1-year mortality through univariate logistic regression analysis. Secondly, the statistically significant variables in univariate analysis were introduced in a multivariate logistic regression model to identify independent predictors of 1-year mortality. The rule of thumb of 5 to 10 events per variable in the multivariate logistic model was applied. There were no missing data in our final database. Therefore, no missing data strategy was required before the statistical analysis. As previously proposed by experts [13] , all patients were screened for SARS-CoV-2 prior to elective surgery and if they were positive, their surgeries were either postponed, if possible, or transferred to another center dedicated to managing COVID-19 in surgical patients. There was, however, a small number of patients (5 of 1078) that underwent surgery as emergencies having COVID-19; therefore, no general considerations can be made regarding increased mortality in COVID-19 patients as mentioned by other authors [14] . There were 1078 surgical patients in our department in 2020. The monthly distribution of surgeries is shown in Figure 2 . When compared to the previous year (2019), the number of surgical patients corresponded to a reduction of 30% in surgical activity. The cohort demographic and surgical characteristics are shown in Table 1 . The mean patient age was 59±14 years and 542 (50.28%) patients were female; 655 (60.76%) patients underwent a major surgical procedure; 663 (61.45%) interventions were performed in an oncological context; 216 (20.04%) were emergency surgeries; and 693 (64.3%) had an ASA score ³III. The overall perioperative mortality was 3.25% (35 patients). The monthly variation of recorded mortality is shown in Supplementary Figure 1 . e935809-3 Variables * Comparison between pandemic and extra pandemic period. ** Comparison between wave period and the rest of the pandemic period. IQR -interquartile range; ASA -American Society of Anesthesiology risk score; PRBC -packed red blood cells. Patients' characteristics are shown by the extra-pandemic, pandemic, and wave periods in Table 1 Figure 2) , ASA category, proportion of emergency surgery (proportion of the emergency interventions recorded monthly are shown in Supplementary Figure 3) , and need for reintervention (Supplementary Figure 4) , but there were differences in ASA category between wave-period and outside-of- In our cohort, we did not find an increased perioperative mortality during the COVID-19 pandemic, despite an increase in surgery complexity, as shown by the higher proportion of major surgery (defined as surgery longer than 90 min), as well as the longer median duration of the interventions. These results are reassuring, considering the huge pressure on ICU beds and medical personnel during the pandemic. As expected, the elective surgery activity diminished [2] . However, the study design could not directly evaluate the mortality of delayed, rescheduled, or cancelled surgical interventions, nor medium or long-term postoperative mortality. The decline in our surgical activity was more important following the issue of the emergency state (Figure 2 ). This allowed for reorganization of the activity and better distribution of local healthcare resources and adoption of pandemic precautions as generally stated. There are some explanations for our findings that disprove the research hypothesis. Firstly, the reduction in surgical activity allowed for a better logistical and resource allocation. This OR -odd ratio; CI -confidence interval; PRBC -packed red blood cells; ASA -American Society of Anesthesiology risk score. was possible because our tertiary center is not involved in the main local and regional emergency pathway but provides highly specialized expertise when requested [15] . Secondly, the local medical personnel are already accustomed to difficult and continuously changing logistic conditions [7] . More major surgeries were performed during the pandemic months, which is explainable as these cases were prioritized by the restrictive surgical planning, and their proportion increased. Minor surgeries were more likely to be postponed. Also, it is possible that other centers reoriented these patients due to the already mentioned logistical issues, which led to some general hospitals becoming dedicated COVID-19 enters and closing elective surgical activity altogether [6] . The preponderance of patients with a better general condition during the wave compared with those outside the wave, as indicated by the ASA category differences, suggested there could have been a selection bias during the wave toward healthier patients with fewer comorbidities, which could maximally benefit from surgery. This was not found, however, when comparing pre-pandemic to pandemic patient characteristics. The main outcomes did not seem to change with the wave period. This finding might be explained by the fact that it was anticipated, and the operating schedule was even more reduced. The ICU had not been overwhelmed at any time. Perioperative bleeding was statistically different between the pre-pandemic and pandemic cohorts: 5 (1.56%) vs 9 (1.19%) patients (P<0.001), but the clinical significance was minimal, given the low incidence. Also, there was no observable impact of the wave period on bleeding. Intraoperative PRBC transfusion remained low and did not differ either between pre-pandemic and pandemic levels or in regards to the wave period, suggesting a good adherence to previously issued patient blood management recommendations, for which our institution was a pilot center [16] . The perioperative mortality in our cohort was higher than that reported in other multicenter international cohorts (3.5% vs 1.5%) [17] . However, our cohort was similar to the usual activity, showing more severe patients (higher ASA score III vs I-II) and an older population, which was not different from that of pre-pandemic months. A second explanation is that we did consider emergency surgeries, not only elective patients, as reported in this international cohort. There has been evidence during the pandemic that providing COVID-19-free surgical pathways is beneficial for patients in terms of mortality, respiratory complications, and SARS-CoV-2 infections [18] . Given the very low number of operated COVID-19 patients, the strict adherence to preoperative screening, as well as the protocol for transfer to dedicated COVID-19 centers, we believe our results confirm this hypothesis. However, there were considerably fewer patients who underwent surgery during the pandemic year, which also includes 2.5 months previous to the decree of the emergency state, as compared with the previous year. The effect of postponing or cancelling these surgeries has not been addressed by our study and remains a potential cause of excess mortality at a regional and national level [19] . The strength of this study is that it shows data of epidemiological and public health interest from a large Eastern European surgical center during the COVID-19 pandemic with a clear and simple methodological design. To the best of our knowledge, this is the largest Eastern European study addressing this issue. The first limitation of this study is its single-center and observational design. However, we already pointed out above that our center has a specific role in the local national healthcare system, with very specialized surgical activity. Another limitation is the small number of variables considered in the data analysis. Other confounding factors could have had an impact on surgical mortality. Unfortunately, the database was not initially created with the purpose of exhaustively analyzing perioperative mortality. However, this limitation might generate an indiscriminative bias, affecting both pandemic and non-pandemic patients in data analysis, thus keeping the findings relevant in the current context. Also, the database was robust, without any missing data. Ideally, the patients needed to be compared with those of the previous years, considering the same months of the year. This is another limitation of this study. However, we assumed that surgical activity is not mainly season-or month-dependent. Despite considerable challenges regarding logistics and personnel, perioperative mortality was similar to pre-pandemic practices in our cohort, that of a tertiary care, academic hospital, the main center of liver transplant and a major center for abdominal surgery in an Eastern European country. This seems reassuring at a local level and should be regarded as a potential model for clinical practice. Special consideration should be given to pandemic waves, when surges of patients can lead to selection of less ill patients, with difficult to estimate consequences on mortality on a national level. Efforts should be made to optimize personnel issues, while maintaining COVID-19-free surgical pathways to adequately address surgical needs during following waves of the pandemic. This study was conducted in Fundeni Clinical Institute, Bucharest, Romania. The study was approved by the local ethics committee. Due to the observational nature of the study, informed consent was waived. The study complied with the tenets of the Declaration of Helsinki, Ethical Principles for Medical Research Involving Human Subjects. The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. All figures submitted have been created by the authors who, confirm that the images are original with no duplication and have not been previously published in whole or in part. Except Figure 1 : Source: https://datelazi.ro/ -official platform on COVID-19 from the Romanian Government. Organ Transplantation is considered an urgent surgical procedure, thus both the donor, as well as the recipient must be tested for COVID-19. Ministry of Health and National Health Insurances House Order nr 539/437/2020 is issued, stipulating the prolongation of the regulation of the Ministry of Health and National Health Insurances House Order nr. 397/836/2018 regarding the approval of bundled services and the framework agreement that stipulates the conditions of granting medical care, medication and medical devices within the Social Security Health system for 2018-2019, the prorogation of certain terms and the implementation of health policies throughout the state of emergency. Care Medicine announces an international humanitarian mission based in Italy, with teams comprising emergency medicine and anesthesia and intensive care medical doctors and certified nurse practitioners. Emergency situations department issues a plan to organize and optimize intensive care units: assigning a coordinator responsible for COVID-19 matters, epidemiological assessment of ICU personnel, optimization of shifts schedule in both COVID and non-COVID areas, sufficient O2 supplies to meet O2 demands, minimizing the risk of contamination among healthcare professionals working in non-COVID areas. A specific protocol is issued about the management of the deceased with confirmed SARS-CoV-2 infection. Supplementary Table 1 Immediate and long-term impact of the COVID-19 pandemic on delivery of surgical services Elective surgery cancellations due to the COVID-19 pandemic: Global predictive modelling to inform surgical recovery plans: Elective surgery during the SARS-CoV-2 pandemic Mortality from COVID-19: A cross-country comparison of containment versus mitigation strategy The first eight months of Sweden's COVID-19 strategy and the key actions and actors that were involved The Lancet. India under COVID-19 lockdown Listei spitalelor care asigură asistenţa medicală pacienţilor testaţi pozitiv cu virusul SARS-CoV-2 în faza I și în faza a II-a și a Listei cu spitalele de suport pentru pacienţii testaţi pozitiv sau suspecţi cu virusul SARS-CoV-2 Migration of skilled anaesthesiologists from low to high-income economies: Urgent action needed Managing ICU surge during the COVID-19 crisis: Rapid guidelines 55 din 15 mai 2020 privind unele măsuri pentru prevenirea şi combaterea efectelor pandemiei de COVID-19. Publicat în MONITORUL OFICIAL nr. 396 din 15 mai 2020 [serial online The strategy management of a SARS-CoV-2 outbreak in an Eastern European hospital European Centre for Disease Prevention and Control. ECDC country visit to Romania to discuss antimicrobial issues: 26 10 195 din 16 martie 2020 privind instituirea stării de urgenţă pe teritoriul României. Publicat în MONITORUL OFICIAL nr Surgery and COVID-19 Factors associated with surgical mortality and complications among patients with and without coronavirus disease 2019 (COVID-19) in Italy Isolated liver trauma. A clinical perspective in a non-emergency center for liver surgery Perioperative Patient Blood Management Programme. Multidisciplinary recommendations from the Patient Blood Management Initiative Group Outcomes from elective colorectal cancer surgery during the SARS-CoV-2 pandemic Elective cancer surgery in COVID-19 -free surgical pathways during the SARS-CoV-2 pandemic: An international, multicenter, comparative cohort study Exploring the gap between excess mortality and COVID-19 deaths in 67 countries Institutional level 24.03.2020 Outlining general control measures to break chains of transmission of SARS-CoV-2 within the hospital: • All personnel shall comply with the triage procedures by completing the dedicated form and measuring their temperature at the beginning of their working hours. • Suspected cases among the healthcare workers shall be reported by the head nurse to the chief physician. • Interpersonal communication among professionals shall be conducted via telephone, thus limiting unnecessary contact and movement between hospital departments. • Establishing a reasonable shift schedule for nurses and other healthcare workers, who are going to work strictly in only one designated section of the ward throughout the entire pandemic period (no ward changes are allowed) • Only designated medical personnel is allowed to enter patient rooms • Entry and exit should be minimized and limited to: providing treatment, clinical examination, nursing, serving meals, cleaning, and decontamination • To the extent possible, a maximum of 2 patients should be housed in the same room during the pandemic period • All personnel should strictly comply with the protective health measures before entering patient rooms • All health workers must comply with the hand hygiene practices • All personnel is required to wear a simple facemask at all times when in contact with patients who are not suspected/ confirmed COVID-19 cases • PPE (personal protective equipment) and biohazard containers must be always available • A dedicated room must be assigned for isolation and medical treatment of suspected COVID-19 cases. 20.05.2020 ICU III will have two remunerated doctors on duty. Red zone is attended by the second line on duty who may be contacted on the ICU III dedicated telephone. Public Health District Authority of Bucharest proceeds to the annulment of the order stipulating that "all medical personnel is prohibited from working during the COVID-19 pandemic in any other medical facility than the one they are employed in".24.06.2020 ICU consultations throughout COVID-19 pandemic: limitation of medical consultations for terminally ill patients who are beyond medical rescue; these cases shall be undertaken by the attending doctor/head chief, thus ensuring a better management of the scarce medical and human resources in ICU. Epidemiological investigations carried out in clinical wards require in case of COVID outbreaks the following measures to be adopted: Minimizing admissions for a period of at least 5 to 7 days, transferring COVID patients to dedicated hospitals, non COVID emergencies shall be redirected to other wards in FCI or other agreed-upon hospitals, all personnel must be tested.