key: cord-0909743-fwlricty authors: Dinçer, Müşerref Beril; Güler, Meltem Merve; Kaan Gök, Ali Fuat; İlhan, Mehmet; Orhan-Sungur, Mukadder; Özkan-Seyhan, Tülay; Koltka, Ahmet Kemalettin title: Evaluation of Postoperative Complication with Medically Necessary, Time-Sensitive Scoring System During Acute COVID-19 Pandemic: A Prospective Observational Study date: 2021-06-07 journal: J Am Coll Surg DOI: 10.1016/j.jamcollsurg.2021.05.028 sha: dca962c5c4a3c0f0049e8d4b99536d8d54eb336d doc_id: 909743 cord_uid: fwlricty BACKGROUND: High scores in Medically Necessary, Time-sensitive (MeNTS) scoring system, used for elective surgical prioritization during Coronavirus Disease 2019 pandemic, are assumed to be associated with worse outcomes. We aimed to evaluate the MeNTS scoring system in patients undergoing elective surgery during restricted capacity of our institution with or without moderate or severe postoperative complications. STUDY DESIGN: In this prospective observational study, MeNTS scores of patients undergoing elective operations during May-June 2020 were calculated. Postoperative complication severity (classified as Group Clavien-Dindo 24 hours but less than <2 weeks of admission (eg: cardiothoracic / cardiovascular procedures, cerebral aneurysm repair, closed fractures, spinal fractures and acetabular fractures, scheduled cesarean section) J o u r n a l P r e -p r o o f -Essential elective: Procedures that can be performed within 1-3 months (eg: cancer surgery and biopsies, hernia repair, hysterectomy, reconstructive surgery) -Discretionary elective: Cases that can be performed >3 months (eg: cosmetic surgery, bariatric surgery, joint replacement, sports surgery, infertility procedures) Following Ethics Committee Approval (2020/691), we screened all patients undergoing operation in the aforementioned dates and enrolled eligible patients who gave written informed consent for the study. Exclusion criteria were age <18 years, and refusal of enrollment or communications problems causing a barrier for consent. Likewise, patients who had to be operated within 24 hours, were not included in this study ( Figure 1 ). During this period of time, our institutional policy was to question all patients before surgery regardless of their emergency status for COVID-19 symptoms and take nasopharyngeal swab samples for Polymerase Chain Reaction (PCR) test (Bio-speedy® Direct RT-qPCR SARS-CoV-2, Bioeksen Ar-Ge Tek. Ltd., Turkey). Urgent elective cases other than cesarean sections also had thoracic computed tomography (CT) scans performed according to surgeon discretion as test turnover time at that period was >24 hours in our institution. We included only cesarean section patients who were classified as planned or elective (Category III and IV) according to Royal College of Obstetrics and Gynaecologists. 14 Patients' demographic data, characteristics (type of surgery and urgency, American Society of Anesthesiologists (ASA) physical status class, history of smoking and cancer) as well as COVID-19 screening including PCR tests and/or thoracic CT scans, clinical symptoms and signs in favor of COVID-19 such as fever, cough, dyspnea and abnormality in laboratory parameters including lymphocyte and leukocyte count, C-reactive protein (CRP) values were recorded. MeNTS scores as well as Duke Activity Status Index (DASI) scores that estimate functional capacity were calculated as proposed. 12, 15 The surgical evaluation for MENTS score was performed by the most experienced surgeon on the surgical team and J o u r n a l P r e -p r o o f verified by one of the surgeon investigators (A.F.K.Gök). Following operation, type of anesthesia (general, neuraxial, peripheral nerve block) and duration of surgery were recorded. Post-operative pulmonary complications (PPCs) 16 , postoperative major adverse cardiac and cerebrovascular events (MACCEs) 17 in the first postoperative month were also recorded. All postoperative complications of the patients were evaluated and graded by using Clavien-Dindo classification. 18 Intensive care requirements for the first 14 postoperative days, length of ICU stay, total length of hospital stay, rehospitalization, presence of active COVID-19, mortality within 30 days were also investigated. This study was an observational exploratory study limited to a certain period with restricted capabilities. As we did not know how long this period would continue, we were not able to speculate on the sample size but rather screened and approached all possible patients in this time period. Patients were classified into two groups according to severity of postoperative complications as Group Clavien-Dindo < II (no or mild complication) or Group Clavien-Dindo ≥ II (moderate or severe complications). Data are given as mean ± SD, median [min-max] or number (%). Quantitative data was evaluated for normal distribution with Shapiro-Wilk and Kolmogorov-Smirnov tests. Normally distributed data was tested between the groups with Student t test, whereas non-normally distributed data was tested with Mann-Whitney U test. Mean difference and its 95% Confidence Interval (95%CI) are also given where applicable. Qualitative data was tested with chi-square tests. Receiver operator characteristic (ROC) curve was generated and the area under the curve (AUC) was calculated to assess the predictive utility of MeNTS and DASI scores. Nasopharynx was swabbed for PCR test sampling in all patients before operation. Number of patients with both preoperative results of PCR testing and thoracic CT scan was 142, whereas the number of patients who preoperatively had the results of only PCR scanning was 53. We were able to acquire the results of PCR testing in 28 patients in the postoperative period. Of these 28 patients, 22 patients had thoracic CT examination before the operation. Six patients who underwent caesarean section did not have either PCR test result or thoracic CT scan before the operation. In these six patients, test results obtained at the postoperative period were negative. One patient whose first preoperative PCR test was negative, was converted to positive postoperatively. That patient did not have any postoperative complications and was discharged per routine. The mean age of patients was 48.5 ± 17.7 years and median body mass index (BMI) was 25 One patient had pulmonary embolism, whereas PPCs were seen in 25 (11.2%) patients and postoperative MACCEs were observed in 9 (4.0%) patients. Table 2 details patients' type of the complications with severity according to Clavien-Dindo classification. The ROC curve determining the performance of MeNTS score for predicting Clavien-Dindo Grade II and above is shown in Figure 3A . At the threshold of 45.5, the sensitivity and specificity of MeNTS score to discriminate the patients with Clavien-Dindo score II and above were 74.7% and 53.5%, respectively. When MeNTS scoring is categorised using the cut-off value of 45.5, there is a significant increase in length of hospital stay, number of J o u r n a l P r e -p r o o f patients with ICU need ≥ 48h and length of ICU stay in patients with MeNTS ≥ 45.5 ( Table 4 ). The ROC curve determining the performance of DASI score for predicting Clavien-Dindo Grade II and above is shown in Figure 3B . At the threshold of 22.07, the sensitivity and specificity of DASI score to discriminate the patients with Clavien-Dindo score II and above were 86.8% and 53.2%, respectively. In this prospective observational study, we found that MeNTS scores were higher in patients who had postoperative moderate or severe complications. MeNTS scoring system is a recently proposed system which was calculated retrospectively in a limited number of patients (n= 41). 12 The authors alluded that higher scores would reflect poorer patient outcomes as, per design, higher scores are assigned to worse situations in procedure and patient factors (such as prolonged surgery or severe disease). Understandably, as patient outcomes were not the scope of this proof of concept study, the only result noted was that Age and ASA physical status class is higher in Group Clavien-Dindo ≥ II. Presence of smoking which is a known factor for perioperative complications is also encountered more frequently in this group. 33 Regarding abnormal preoperative laboratory evaluations, leukocytosis is long associated with perioperative complications, morbidity and mortality in colorectal, hepatic, ovarian and cervical disc surgeries. [34] [35] [36] [37] Likewise preoperative elevated CRP is associated with higher morbidity and mortality in abdominal and thoracic cancer surgical patients. 38 There is scant evidence on the possible role of preoperative lymphopenia on postoperative complications. 39 The presence of leukocytosis, lymphopenia and elevated CRP in our study are also associated with more severe complications. Interestingly, when the patients with ASA physical status classification is proposed and developed to communicate patient comorbidities between anesthesiologists but is often used in combination with other risk scores to predict patient outcomes. 41 Likewise, DASI is a 12 item self-reported questionnaire that measures functional capacity by questioning the ability to perform daily and recreational activities. 15 Although it is basically a cardiopulmonary fitness index, recently, DASI scores less than 34 were shown to identify patients with elevated risk of myocardial injury, infarction, moderate to severe complications including non-cardiac complications such as respiratory failure and new disability. 42 In our study, ASA physical status class was higher and median DASI scores were lower in Group Clavien-Dindo ≥ II. Indeed, we observed very low scores of DASI in patients who died, whereas their MENTS scores were similar to survivors. Furthermore, in this study the observation of AUC of ROC Curve <0.7 highlights relatively low discriminating power of MeNTS score for prediction of Group Clavien Dindo ≥ II. MeNTS score, although inquiring the presence of some comorbidities (pulmonary disease, obstructive sleep apnea, cardiovascular disease, diabetes and immune deficiency), does not evaluate the functional capacity of the patient. Therefore, other incapacitating J o u r n a l P r e -p r o o f comorbidities or their combinations can be overlooked. Furthermore, scoring of the severity of co-morbidities in MeNTS score is based on drug consumption rather than functional capacity measurement which may be affected by patient compliance to therapy. Last but not the least, MeNTS is not a weighted score, i.e. it does not differentiate whether one factor is more significant than another or not. In our study, the MeNTS scores ranged between 25 and 68, similar to Prachand et al. 12 The cut-off value in predicting moderate or severe postoperative complications was 45.5 in our study, which was lower than their graphed value for lower threshold of unjustified procedures. One should be aware that MeNTS score, when used for prioritizing, is a dynamic threshold with upper and lower values which should be adapted according to local conditions. One strength of our study is that we did not postpone surgery according to possible complications, disease severity or surgery characteristics. Rather, we continued on operating to eliminate surgical lists created on a first-come-first-serve basis as long as the patients There are several limitations of this study. First, although all surgical fields are represented in our study, not all types of surgeries are included and also their distribution across surgical fields is not uniform. Secondly, we did not include patients who needed to be operated within 24 hours after admission as these patients are exempt from a priority listing. Thirdly, this study includes 223 patients in its analysis which is a low number for an outcome study. However, this was a single centre study restricted to a time period with limited resources which also reflected real conditions where such information may be applicable. MeNTS scores can also decrease risk of COVID-19 transmission to the healthcare team by helping to identify infected patients and hence limit hospital resource use. The scope of this study was patient outcomes by analysing postoperative complications, need for ICU, length of hospital stay and we did not evaluate COVID-19 transmission to the healthcare team. Although there were no reported cases of COVID-19 among anesthesiologists and surgeons, we did not investigate other components of the teams including perioperative nurses and ward personnel. MeNTS score was designed to systematically integrate factors that are novel to COVID-19 pandemic and was proposed to rule the process for decision making and triage for patients during this period. It was considered that higher scores were associated with poorer perioperative patient outcomes. In this prospective observational study, we found that, MeNTS scores were higher in patients with moderate and severe complications as graded ≥ II according to Clavien-Dindo classification. Yet, the discriminating capacity of this scoring system was below acceptable for moderate/severe complications. 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