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.
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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 DesignIn 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 <II or Group Clavien-Dindo ≥ II) as well as Duke Activity Index, ASA physical status, presence of smoking, leukocytosis, lymphopenia, elevated CRP, operation and anesthesia characteristics, intensive care requirement and duration, length of hospital stay, rehospitalization and mortality were noted.
Results223 patients were analysed. MeNTS score was higher in Group Clavien-Dindo ≥ II compared to Group Clavien-Dindo < II (50.98 ± 8.98 vs 44.27 ± 8.90 respectively, p<0.001). Duke activity status index (DASI) scores were lower and American Society of Anesthesiologists physical status class, presence of smoking, leukocytosis, lymphopenia, elevated CRP, intensive care requirement was higher in Group Clavien-Dindo ≥II (p<0.01). Length of hospital stay was longer in Group Clavien-Dindo ≥II (15 [2-90] versus 4 [1-30]; p<0.001). Mortality was observed in eight patients. Area under receiver operating characteristic curve of MeNTS and DASI were 0.69 and 0.71 respectively for predicting moderate/severe complications.
ConclusionAlthough significant, MeNTS score had low discriminating power in distinguishing patients with moderate/severe complications. Incorporation of a cardiovascular functional capacity measure could improve scoring system.
INTRODUCTIONCoronavirus disease 2019 (COVID-19) caused a shift in healthcare and resulted in allocation of large amounts of equipment and human resources to COVID-19 patients.1Emanuel E.J. Persad G. Upshur R. et al.Fair Allocation of Scarce Medical Resources in the Time of Covid-19.,2A Framework for Rationing Ventilators and Critical Care Beds During the COVID-19 Pandemic. The consequence of such an allocation is a mandatory decrease in elective surgeries so as to preserve necessary equipment both disposable (such as personal protective equipment) and non-disposable (such as ventilators) as well as hospital bed capacity and healthcare staff.3Diaz A. Sarac B.A. Schoenbrunner A.R. et al.Elective surgery in the time of COVID-19.,4Bhangu A. Lawani I. Ng-Kamstra J.S. et al.Global guidance for surgical care during the COVID-19 pandemic. Furthermore, the possibility of operating an asymptomatic but undetected COVID-19 patient may cause concern as it is both hazardous to the patient and the staff involved in care.5Aminian A. Safari S. Razeghian-Jahromi A. et al.COVID-19 Outbreak and Surgical Practice: Unexpected Fatality in Perioperative Period.,6Lei S. Jiang F. Su W. et al.Clinical characteristics and outcomes of patients undergoing surgeries during the incubation period of COVID-19 infection. Therefore, many countries declared a temporary postponement of elective surgeries during acute pandemic.However, this disruption in care itself can cause the advancement of the original disease for which the operation was planned with negative outcomes. Additionally, a decrease in surgical volume due to anxiety and fear of health care centers can result in both emotional and economical burdens in the long run.7Meredith J.W. High K.P. Freischlag J.A. Preserving Elective Surgeries in the COVID-19 Pandemic and the Future. Yet, although various societies have established guidelines for the initiation of elective surgery,8Bhat P.K.R. Santosh Kumar K.Y. Sorake C. Kulamarva G. Gastrointestinal Malignancies and the COVID-19 Pandemic: Evidence-Based Triage to Surgery., 9Heldwein F.L. Loeb S. Wroclawski M.L. et al.A Systematic Review on Guidelines and Recommendations for Urology Standard of Care During the COVID-19 Pandemic., 10Chiofalo B. Baiocco E. Mancini E. et al.Practical recommendations for gynecologic surgery during the COVID-19 pandemic. the decision to support elective surgery during pandemic is also complex as no scientific data on outcomes regarding patient prioritisation exist.Medically necessary, time-sensitive (MeNTS) scoring system described by Prachand et al. has been endorsed by American College of Surgeons and it is an objective scoring system to triage and make decisions for the elective surgery in this pandemic process.12Prachand V.N. Milner R. Angelos P. et al.Medically Necessary, Time-Sensitive Procedures: Scoring System to Ethically and Efficiently Manage Resource Scarcity and Provider Risk During the COVID-19 Pandemic. MeNTS score is composed of three components, i.e. procedure, disease and patient factors and calculated using a 5-point scale (eTable 1). The lowest possible score is 21 and the highest 105 with higher scores assumed to be related to worse outcomes or increased risk of transmission and/or increased resource use. In times of restricted capabilities, proper patient prioritization may prevent case backlog and preserve limited resources. In that sense, prioritization scores also combine elements that are associated with perioperative outcomes. Yet, the MeNTS scoring system has not been studied prospectively in relation to patient outcomes. In this observational study, we aimed to compare the MeNTS scoring system in patients undergoing elective surgery with or without moderate or severe postoperative complications.METHODSOur institute is an established university hospital with 40 operation rooms and approximately 150 elective surgeries per day. The Anesthesiology Department is the primary responsible team for 4 intensive care units (ICU) with 38 beds for a mixt population of adult surgical and medical patients excluding cardiovascular surgical and cardiac medical intensive care units. Following the first wave of pandemic, elective surgery was postponed by the Turkish Ministry of Health on March 17th, 2020. At this time, all anesthesiologists and anesthesiology residents were working in the COVID ICU units or for the urgent/emergent surgeries in shifts. However, in May 2020, we were able to resume elective surgery in a restricted capacity, following a decrease in COVID-19 ICU bed requirements. In this period, we allocated 3 to 4 operation rooms for elective surgery and performed about 5-7 operations per day. Again in this period, 15 ICU beds were reserved for the elective cases and non-COVID indications. We resumed full capacity at the end of June according to institutional policy while redirecting COVID-19 patients to dedicated pandemic hospitals. In this observational study, we report the outcomes of urgent-elective, essential elective and discretionary elective cases with restricted capacity (May-June 2020) of our institution. Case priority was defined as follows:13How to risk-stratify elective surgery during the COVID-19 pandemic?.-Urgent-elective: Operations that need to be performed within >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)
-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 Figure 1).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.
RESULTSStatistical analysis included 223 patients, out of which 110 patients (49.3%) had urgent-elective, 108 patients (48.4%) had essential elective and 5 patients (2.2%) had discretionary elective surgery during study period (Figure 1).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 [17-52] kg/m2 with male gender presented in 112 (50.2%) patients. Patients’ surgical characteristics are described in Table 1. The mean MeNTS score of all included patients was 46.65 ± 9.47, and the median DASI score was calculated as 44.70 [2.75-58.2]. General anesthesia was performed in 166 patients (74.4%), 50 patients (22.4%) had spinal anaesthesia and 7 patients (3.1%) had peripheral nerve block. Mean operation time was 105 [15-480] minutes.Table 1Patient Operative Characteristics
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.Table 2Type of Complication by Clavien-Dindo Grade
BPT, blood product transfusion; ERCP, endoscopic retrograde cholangiopancreatography; MODS, multiple organ dysfunction syndrome; PCR, polymerase chain reaction; VAC, vacuum-assisted wound closure.
Table 3 shows the comparison between groups in terms of age, gender, ASA physical status class, BMI, smoking status, leukocytosis, lymphopenia, CRP elevation, MeNTS score, DASI score, type of anesthesia, presence of intubation, duration of operation, presence of malignancy, type of operation, intensive care requirement, length of ICU stay, total length of hospital stay, rehospitalization and mortality. Mean MeNTS score was higher in Group Clavien-Dindo ≥ II compared to Group Clavien-Dindo Figure 2).Table 3Comparison According to Clavien-Dindo Classification
CRP, C-reactive protein; DASI, Duke Activity Status Index; MeNTS, medically necessary, time-sensitive.
Figure 2The box and whisker plot of the scores of procedure-, disease-, and patient-related factors of Medically Necessary Time-Sensitive (MeNTS) score (total) in Group Clavien-Dindo <II (CD <II) and Group Clavien-Dindo ≥II (CD≥II).
Mortality was seen in eight patients (3.59%). Median MeNTS scores were similar in the deceased and alive patients (53.5 [41-61] and 47 [25-68] respectively; p=0.063) whereas median DASI scores were significantly lower in patients who died compared to survivors (3.62 [2.75-18.95] and 45.45 [4.5-58.2] respectively; p<0.001).
MeNTS scores in patients with leukocytosis and elevated CRP were similar to those without elevation (44.53 ± 11.26 vs 46.97 ± 9.15 for leukocytosis, p=0.189; 46.05 ± 9.61 vs 46.76 ± 9.46 for elevated CRP, p=0.682, respectively). Likewise, MeNTS scores in patients with lymphopenia were similar to patients without (47.89 ± 9.04 vs 46.53 ± 9.52, p=0.551).
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 patients with ICU need ≥ 48h and length of ICU stay in patients with MeNTS ≥ 45.5 (Table 4).Figure 3(A) Receiver operator characteristic (ROC) curve determining the performance of Medically Necessary Time-Sensitive (MeNTS) score for predicting Clavien-Dindo Grade II and above. Area under the curve (AUC) = 0.69, 95% CI 0.619–0.762. Sensitivity 74.7%, specificity 53.5%. (B) ROC curve determining the performance of Duke activity status index score for predicting Clavien-Dindo Grade ≥II. AUC = 0.71, 95% CI 0.638 –0.787. Sensitivity 86.8%, specificity 53.2%.
Table 4Hospital Stay, ICU Requirement, and ICU Stay by Classified Medically Necessary, Time-Sensitive Score
MeNTS, medically necessary, time-sensitive.
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.DISCUSSIONIn 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).12Prachand V.N. Milner R. Angelos P. et al.Medically Necessary, Time-Sensitive Procedures: Scoring System to Ethically and Efficiently Manage Resource Scarcity and Provider Risk During the COVID-19 Pandemic. 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 MeNTS scores of cancelled patients (n=6) were high suggesting an agreement with the decisions of the clinical team prior to construction of the scoring system.Operating room scheduling, postoperative planning and patient safety already requires questioning of some components of MeNTS scoring including procedural factors such as operating room time, ICU need, surgical team, surgical site and patient factors such as chronic diseases, medications as a part of routine screening of surgeons and anesthesiologists. But the MeNTS scoring system for prioritization is not studied extensively. Cohn et al have studied the scoring system in terms of its overlap for patient prioritization comparing surgical branch consensus/expert opinion based and individual surgeon based systems19Cohn J.A. Ghiraldi E.M. Uzzo R.G. Simhan J. A Critical Appraisal of the American College of Surgeons Medically Necessary, Time Sensitive Procedures (MeNTS) Scoring System, Urology Consensus Recommendations and Individual Surgeon Case Prioritization for Resumption of Elective Urological Surgery During the COVID-19 Pandemic., whereas others questioned the reliability of modified MeNTS scores for different types of surgical branches for triage.20Marfori C.Q. Klebanoff J.S. Wu C.Z. et al.Reliability and Validity of 2 Surgical Prioritization Systems for Reinstating Nonemergent Benign Gynecologic Surgery during the COVID-19 Pandemic.,21Waxman S. Garg A. Torre S. et al.Prioritizing elective cardiovascular procedures during the COVID-19 pandemic: The cardiovascular medically necessary, time-sensitive procedure scorecard. A modified scoring system for pediatric patients (pMeNTS) was also described by Slidell et al22Slidell M.B. Kandel J.J. Prachand V. et al.Pediatric Modification of the Medically Necessary, Time-Sensitive Scoring System for Operating Room Procedure Prioritization During the COVID-19 Pandemic., and it was mentioned that deferred cases had higher scores similar to the results of Prachand et al.12Prachand V.N. Milner R. Angelos P. et al.Medically Necessary, Time-Sensitive Procedures: Scoring System to Ethically and Efficiently Manage Resource Scarcity and Provider Risk During the COVID-19 Pandemic. However, until our study, score is not evaluated in real life circumstances with postoperative complication and outcome data. This novel study for the first time demonstrates that patients with moderate or severe postoperative complications had higher preoperatively calculated MeNTS scores.Although there are several single organ and composite outcome scores for standardized definitions of postoperative complications,16Canet J. Gallart L. Gomar C. et al.Prediction of postoperative pulmonary complications in a population-based surgical cohort.,23Torres P.D. Botto F. Paz R.V. Vásquez M.J. Myocardial injury after non-cardiac surgery., 24Horan T.C. Andrus M. Dudeck M.A. CDC/NHSN surveillance definition of health care-associated infection and criteria for specific types of infections in the acute care setting., 25Grocott M.P.W. Browne J.P. Van der Meulen J. et al.The Postoperative Morbidity Survey was validated and used to describe morbidity after major surgery. we preferred classification of complication severity via Clavien-Dindo classification as it is popular in a wide variety of surgical fields.26Wang W.G. Babu S.R. Wang L.I. et al.Use of clavien-dindo classification in evaluating complications following pancreaticoduodenectomy in 1,056 cases: A retrospective analysis from one single institution., 27Yoon P.D. Chalasani V. Woo H.H. Use of Clavien-Dindo Classification in Reporting and Grading Complications after Urological Surgical Procedures: Analysis of 2010 to 2012., 28Vallur S. Dutta A. Arjun A.P. Use of Clavien–Dindo Classification System in Assessing Head and Neck Surgery Complications., 29Hébert M. Cartier R. Dagenais F. et al.Standardizing Postoperative Complications—Validating the Clavien-Dindo Complications Classification in Cardiac Surgery. This classification can differentiate between mild complications that result in either temporary harm and/or can be rectified with brief intervention and severe complications that may result in increased hospital stay, disability and/or permanent function loss and possible death.30Clavien P.A. Barkun J. De Oliveira M.L. et al.The clavien-dindo classification of surgical complications: Five-year experience., 31Duraes L.C. Stocchi L. Steele S.R. et al.The Relationship Between Clavien–Dindo Morbidity Classification and Oncologic Outcomes After Colorectal Cancer Resection., 32Bolliger M. Kroehnert J.A. Molineus F. et al.Experiences with the standardized classification of surgical complications (Clavien-Dindo) in general surgery patients. In this sense, neither Grade 0 (no complication), nor Grade I (any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions) may result in a possibility of prolongation and/or aggravation of the postoperative course.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.33Grønkjær M. Eliasen M. Skov-Ettrup L.S. et al.Preoperative Smoking Status and Postoperative Complications.Regarding abnormal preoperative laboratory evaluations, leukocytosis is long associated with perioperative complications, morbidity and mortality in colorectal, hepatic, ovarian and cervical disc surgeries.34Moghadamyeghaneh Z. Hanna M.H. Carmichael J.C. et al.Preoperative leukocytosis in colorectal cancer patients., 35Beetz O. Weigle C.A. Cammann S. et al.Preoperative leukocytosis and the resection severity index are independent risk factors for survival in patients with intrahepatic cholangiocarcinoma., 36Barber E.L. Boggess J.F. Van Le L. et al.Association of preoperative thrombocytosis and leukocytosis with postoperative morbidity and mortality among patients with ovarian cancer., 37Zreik J. Goyal A. Alvi M.A. et al.Utility of Preoperative Laboratory Testing in Assessing Risk of Adverse Outcomes After Anterior Cervical Discectomy and Fusion: Insights from National Surgical Registry. Likewise preoperative elevated CRP is associated with higher morbidity and mortality in abdominal and thoracic cancer surgical patients.38Abilities of Pre- and Postoperative High-Sensitivity C-Reactive Protein Levels to Predict 90-Day Mortality After Surgery for Abdominal and Thoracic Cancers. There is scant evidence on the possible role of preoperative lymphopenia on postoperative complications.39Chiarelli M. Achilli P. Tagliabue F. et al.Perioperative lymphocytopenia predicts mortality and severe complications after intestinal surgery. The presence of leukocytosis, lymphopenia and elevated CRP in our study are also associated with more severe complications. Interestingly, when the patients with these abnormalities are compared to those without, MeNTS scores were similar. MeNTS score, as a part of patient factors, questions the presence of influenza-like illness (fever, cough, body aches, sore throat, diarrhea) for COVID symptoms but does not incorporate laboratory values similar to other prioritization scores or modifications proposed19Cohn J.A. Ghiraldi E.M. Uzzo R.G. Simhan J. A Critical Appraisal of the American College of Surgeons Medically Necessary, Time Sensitive Procedures (MeNTS) Scoring System, Urology Consensus Recommendations and Individual Surgeon Case Prioritization for Resumption of Elective Urological Surgery During the COVID-19 Pandemic., 20Marfori C.Q. Klebanoff J.S. Wu C.Z. et al.Reliability and Validity of 2 Surgical Prioritization Systems for Reinstating Nonemergent Benign Gynecologic Surgery during the COVID-19 Pandemic., 21Waxman S. Garg A. Torre S. et al.Prioritizing elective cardiovascular procedures during the COVID-19 pandemic: The cardiovascular medically necessary, time-sensitive procedure scorecard., 22Slidell M.B. Kandel J.J. Prachand V. et al.Pediatric Modification of the Medically Necessary, Time-Sensitive Scoring System for Operating Room Procedure Prioritization During the COVID-19 Pandemic. which may be a limitation of the scoring. Questioning of COVID symptoms/exposure may seem redundant in this era given that PCR testing is an accepted standard for surgery during pandemic. However, PCR testing can have false negative results
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