key: cord-0744203-v0r0kt45
authors: Couto, Rafael A; Wiener, Thomas C; Adams, William P
title: Evaluating Postoperative Outcomes of Patients Undergoing Elective Procedures in an Ambulatory Surgery Center During the COVID-19 Pandemic
date: 2020-06-29
journal: Aesthet Surg J
DOI: 10.1093/asj/sjaa180
sha: 70809552f2a6e51d9e95e13e07142fcf93b8bab2
doc_id: 744203
cord_uid: v0r0kt45

BACKGROUND: Despite the rapid rise of publications pertaining to COVID-19, there is a lack of data examining patient outcomes following elective procedures performed during this pandemic. OBJECTIVES: The purpose of this investigation is to: 1) examine the postoperative outcomes of patients that underwent elective procedures in an ambulatory surgery center during the COVID-19 pandemic; 2) share the preoperative screening and patient selection protocol implemented in our center. METHODS: Elective procedures performed in an ambulatory surgery center between March 1, 2020 and April 16, 2020 were retrospectively reviewed. The primary outcomes were occurrence of COVID-19 related postoperative complications. These complications include pneumonia, stroke, myocardial infarction, and clotting disorders. Predictive variables analyzed in this study were: age, American Society of Anesthesiologist (ASA) score, and specialty conducting the procedure, operating time, and the type of plastic and reconstructive surgery procedure being performed. RESULTS: A total of 300 consecutive electives cases were included in the study. The most common procedures were pain management (43.0%), gastrointestinal (26.0%), aesthetic (14.0%), orthopedic (10.3%), reconstructive (4.0%), otorhinolaryngology (2.0%), and gynecology (0.67%). The median age of the cohort was 54.6 years (range, 1-90 years) and the median procedure time was 47 minutes (range, 11-304 minutes). COVID-19 related symptoms or complications following the procedures were not observed in any of the patients nor the healthcare care personnel. CONCLUSIONS: In this cohort of 300 electives cases, we found no patients with COVID-19 related symptoms postoperatively. This suggests that with proper preoperative screening and patient selection, elective procedures can be safely performed in an ASC during this pandemic.

A c c e p t e d M a n u s c r i p t As the novel coronavirus-2 (SARS-COV-2) swept across the globe, the coronavirus 2019 pandemic has paralyzed our society, economy, and healthcare system. Elective surgical procedures are among the elements disrupted in both in hospitals and ambulatory surgery centers (ASC). In an attempt to maximize medical resources and minimize infection rates, on March 13, 2020, the American College of Surgeons issued a recommendation to "minimize, postpone, or cancel electively scheduled operations." 1 Almost two months later, while the state of Texas is strategically re-opening the economy, the Governor has lifted the restriction on performing elective procedures.

Although there is a rapid rise of publications pertaining to this virus and its overall disease state, there is a paucity of data examining the postoperative outcome of patients undergoing elective procedures during this crisis. In other words, is it still safe for us to perform elective surgery? The only study examining postoperative outcomes following elective procedures during this pandemic has considerable demographical and epidemiological limitations, which render their data difficult to apply to other healthcare settings. 2, 3 As we move forward in restarting our practices, the safety of our patients and medical personnel, as always, remains the main priority. Therefore, the objective of this study is to examine the postoperative outcomes of patients that underwent elective procedures in an ASC during the pandemic and share the preoperative patient screening and selection protocol implemented in our center.

A retrospective review of all elective cases performed in an ASC in Dallas, Texas between March 1, 2020 and April 16, 2020 was performed. Guidelines of the Declaration of Helsinki were followed. The ASC's monthly de-identified procedure data sheet was reviewed, and all the physicians were surveyed for any potential postoperative COVID-19 related complications with their patients or any of the medical staff. The primary outcome was occurrence of COVID-19 related symptoms postoperatively. These complications include pneumonia, stroke, myocardial infarction, and clotting disorders. Predictive variables analyzed in this study were: age, American Society of Anesthesiologist (ASA) score, specialty conducting the procedure, operating time, and the type of plastic and reconstructive surgery procedure being performed. As the COVID-19 outbreak unfolded, our ASC immediately applied a rigorous protocol for preoperative screening and selection of patients derived from recommendations from the multiple organization including The Aesthetic A c c e p t e d M a n u s c r i p t Society: Covid-19 Safety Taskforce. 4, 5 This protocol is delineated below.

We ask the patient to self-monitor by taking their temperature and check for any symptoms such as, fever, cough, shortness of breath, malaise, diarrhea, loss of taste/ smell. Furthermore, we instruct the patient to call their primary care physician immediately if they develop any symptoms.

Patients undergo a telephone screening. During this phone call, our nurses utilize the most recent screening guidelines provided by United Surgical Partners International. Any positive responses resulted in a delay of procedure and would recommend patients to self-quarantine and to follow the current US Centers for Disease Control and Prevention (CDC) recommendations for testing.

Both patients and visitor/guardian (of which we only allowed one) must wear a mask. If they do not have a mask, one was provided to them on arrival. With the exception of pediatric or incapacitated patients, we advise the visitor/guardian to not accompany the patient after check-in in the facility during the preoperative stage. They were asked to wait outside the facilities or at home during the procedure. Visitors/guardians were routinely updated via phone about the status of the procedure, and upon completion of the procedure.

Upon arrival, the patient was greeted by one of our staff. Staff wear gloves, mask and face shields. At this time, patients and visitors were screened for potential COVID-19 symptoms, including temperature scanning. If patient and/or visitor had a temperature 100 o F or higher, we would isolate them and serially record the patient's temperature for a span of 30-60 minutes. If consistent fever was noted, then we would reschedule the procedure, and ask the patient to practice social isolation/quarantine and to follow the current US Centers for Disease Control and Prevention (CDC) recommendations for testing.

Cleared patients enter the ASC and proceed to the individual registration bay. A specialized sneeze guard was installed on each of the registration counters. The registrant was instructed to wear a mask at all times.

After registration, patients would proceed alone to the preoperative unit. Only visitors/guardians of pediatric or incapacitated patients are allowed to accompany the patient A c c e p t e d M a n u s c r i p t to the preoperative unit. Although a large waiting room is available family members were asked to wait in their car, in the plaza outside, or in a nearby establishment.

At the preoperative unit, all staff members are instructed to wear an N-95 mask or 3ply OR masks, gloves, and face shields if desired. Meticulous hand hygiene before-and-after treating/ preoperative was mandated.

In the operating room, the anesthesiologist and circulating nurse were the only personnel allowed during intubation and extubation. The staff is required to wear N95 masks and recommended to wear protective equipment as well. Surgeons/surgical teams donned N95 masks for higher risk airway procedures; however, surgeons and team members wore masks of choice for other procedures.

Patients were always extubated in the operating room before transport to the postoperative anesthesia recovery unit. Patients are treated by one recovery room nurse from arrival to discharge to minimize provider-patient interactions.

A total of 300 consecutive elective cases were included in the study (mean age, 27 years; range, 1-90 years). The median procedure time was 47 minutes (range, 11-304 minutes) ( Table 1 ). The cases included: pain management (43.0%), gastrointestinal (26.0%), aesthetic (14.0%), orthopedic (10.3%), reconstructive (4.0%), otorhinolaryngology (2.0%), and gynecology (0.67%) ( Table 2) . Seventy-five aesthetic and reconstructive procedures were performed: mastopexy (12.0%), liposuction (12.0%), breast implant exchange (10.7%), breast augmentation (9.3%), Mohs reconstruction (9.3%), blepharoplasty (8.0%), CO2 laser (6.7%), facelift & necklift (6.7%), abdominoplasty (5.3%), rhinoplasty (4.0%), breast fat grafting (2.7%), breast reduction (2.7%), closed nasal reduction (2.7%), gluteal augmentation with fat transfer (2.7%), abdominoplasty revision (1.3%), breast augmentation-mastopexy (1.3%), and buccal fat resection (1.3%) ( Table 3 ). The majority of the patients had an ASA score of 2 (44.7%), followed by 3 (33.0%), 1 (22.0%), and 4 (0.3%). The most common anesthesia modalities were IV sedation (56.3%), followed by general anesthesia (32.0%), MAC (8.0%), and blocks (2.7%) ( Table 1) . Documented positive COVID-19 diagnoses or COVID-19 related symptoms following the procedures were not reported in any of the patients nor the healthcare care personnel. One preoperative nursing staff was diagnosed with COVID-19; however, she had elected not to work in the center during this period and her husband had contracted COVID-19 elsewhere. The mean follow-up time for physicians, patients, and health care personnel was the 6-week perioperative period. Although urgent elective A c c e p t e d M a n u s c r i p t procedures were performed throughout this time period, elective aesthetic and reconstructive surgery cases were stopped after recommendations by the state of Texas.

The rapid progression of COVID-19 has caused an unprecedented disruption in our Furthermore, they showed that age, comorbidities, especially hypertension and cardiovascular disease, complexity of surgery (ie, Levels 2 and 3), and operating time were possible risk factors for ICU admission. 3 They suggested that surgery and operating time were risk factors for exacerbation and increase severity of COVID-19 symptoms. While this study provides important information, it has a number of flaws and limitations, particularly with respect to epidemiological and demographical characteristics that make this data less applicable to ASCs within the United States. This study was conducted in a hospital in Wuhan, Hubei Province of China, the city where COVID-19 outbreak originated, just weeks after its first reported case of COVID-19. 6 At such an early stage, the recognition of this disease was not evident, thus, proper preoperative screening and patient selection most likely had not yet been implemented in this institution. Another major flaw of this study is that it is not known when the patients contracted COVID-19. The authors assume that the patients were infected during surgery because the average onset of symptoms following the surgery was 5 days. However, it is inaccurate to conclude that this represents outcomes for asymptomatic COVID-19

patients. There is a high likelihood that these patients contracted the disease from a nosocomial exposure postoperatively.

Furthermore, 58.8% of the patients had at least one comorbid condition, including malignancy (26.2%) and cardiovascular disease (20.6%). The case mix of the Chinese study including esophageal and renal carcinoma resections was also quite dissimilar to typical ASC elective procedure. In the current situations, these high-risk patients would have undergone a more rigorous screening and testing before undergoing elective surgery. It is for these reasons that we have decided to present our data, as it depicts a patient population, and a clinical A c c e p t e d M a n u s c r i p t setting that is sounder with the majority of ASCs in the United States.

Our study demonstrated that with proper preoperative screening and patient selection, elective procedures could be safely performed during this time of crisis, and perhaps most importantly, this suggests that we can maintain excellent patient safety during similar future outbreaks with the protocols we have established within our practice. Preoperative screening consisted of a comprehensive medical history and physical examination. Since reliable diagnostic tests were not readily available at the time of the procedures, none of these patients underwent diagnostic testing prior to their procedure. Instead, in any patient with symptoms or risk factors relevant to COVID-19 their procedure was delayed. Now that tests are becoming more available, our there is a strong drive for testing all patients preoperatively, as it theoretically will help identify patients that are either asymptomatic or have mild symptoms. This patient population would be the primary target in outpatient facilities; however, the benefit of this widespread testing is determined by the accuracy of these tests and this currently is not established. In fact, even the original CDC real time polymerase chain reaction (RT-PCR) test has turned out to have a 35% false negative rate and now with over 90 different tests available, both RT-PCR and antibody, it is not clear whether the tests are reliable, available, and reproducible to make widespread preoperative testing a reality.

Our center has not mandated universal testing for these reasons, and the reality is that the current testing accuracy and time lag prevents it from being realistic to do it every patient at this time point. A recent CDC report shows that the overall symptomatic case fatality rate COVID-19 is 0.4%. 7 The same CDC report also cites that 35% of patients are asymptomatic and they are not included in that rate, thus, the Infection Fatality Rate (IFR) ratio will be lower as it takes into account both symptomatic and asymptomatic patients. Furthermore, given the recent remodeling of the actual mortality and hospitalization rate of COVID-19, which approximates seasonal flu, 8 we must ask whether universal preoperative testing for influenzas should be implemented in addition to COVID-19 testing. Alternatively, routine screening and temperature checks has worked quite well for screening seasonal flu patients and based on the data from our series also has worked similarly with COVID-19.

Currently, the recommended diagnostic test is RT-PCR of nasopharyngeal swab samples. Nonetheless, the accuracy of these RT-PCR tests is limited, as the only reported sensitivity and specificity have been in non-peer reviewed articles. 9 Ren et al reported a sensitivity and specificity of 78.2% and 98.8%, respectively. 10 Furthermore, the sensitivity for patients with mild symptoms was 62.5% and the negative predictive value of the test is poor; thus, a single negative result does not rule out COVID-19. On the other hand, several A c c e p t e d M a n u s c r i p t peer-reviewed articles have reported false negative results with RT-PCR tests as described below. 11, 12 Based on all of this, we question the logic of universal testing until a quick bedside "pregnancy like" test for COVID-19 is available. It is important to note that COVID-19 preoperative screening tests were not performed in this studied patient population; however, now that tests are readily available, preoperative COVID-19 screening tests are performed on patients that are high risk for exposure (eg, medical health worker), medical comorbidities, or undergoing facial surgery. Based on the experience in this study, and now another two months of procedures after this dataset was analyzed with similar outcomes, the need for routine blanket testing should be re-assessed.

Another key issue is the concept of the asymptomatic patient that is screened negative, normal temperature, and if any testing has been performed, returns as negative.

Current data suggest that COVID-19 was in the United States in December 2019 and perhaps earlier. [13] [14] [15] Asymptomatic patients comprises of 35% of the population infected with COVID-19, and it is highly likely that many elective procedures were done on asymptomatic COVID-19 patients earlier this year. Additionally, it is known that 20% of influenza cases are asymptomatic and by default that would mean that thousands of elective surgeries are done every year on asymptomatic flu carriers; 16 however, there have been no unexplained postoperative complications in healthy patients, which would question the logic of assuming asymptomatic COVID-19 patients would have a problem with elective surgery. Preoperative testing, since it is not routinely done during influenza season in the asymptomatic patient, and since the influenza viruses and COVID-19 appear to act in a similar fashion regarding the potential for severe complications (especially in susceptible patients), does not seem to be indicated due to the data not showing significant postoperative morbidity occurring in the low risk population. Of course, it goes without saying, that if symptoms exist, especially in a high-risk group, and surgery is important, but potentially able to be delayed, testing may be worthwhile.

There has been several reports of an association between COVID-19 and Kawasakilike inflammatory response in the pediatric population. [17] [18] [19] [20] Although the etiology of Kawasaki disease is unknown, there is substantial data suggesting that it is likely due to a viral etiology. [21] [22] [23] [24] [25] [26] [27] [28] The viruses has been associated to Kawasaki Disease, include Influenza, Enterovirus, Adenovirus, Rhovirus, RSV, Varicella, Epstein-Barr, measles, and dengue. [21] [22] [23] [24] [26] [27] [28] Furthermore, association between Kawasaki disease and coronavirus have been previously described. It has been hypothesized that certain pediatric patients may be genetically predisposed to a hyper inflammatory response to specific viruses and manifest a A c c e p t e d M a n u s c r i p t spectrum of Kawasaki Disease. 25 Our study included seven patients that were 21 years and younger, and there was no report of hyperinflammatory issues. This is an evolving spectrum of COVID-19 infections, and there is much to learn; however, we must put these findings in context of what is already known and be careful of not creating new clinical diagnosis or exaggerating previous clinical entities because of its association with COVID- 19. 25 Further, the concerns regarding COVID-19 and coagulopathies, stroke, myocardial infarction, and respiratory failure are known to occur in patients with both influenza A and B. 29 Published studies describe these medical conditions, and as mentioned, tend to occur in more critically ill patients. These problems may be more an effect of critical illness rather than a specific strain of viral infection. 30, 31 Laboratory-confirmed respiratory infections as triggers for acute myocardial infarction and stroke: a self-controlled case series analysis of national linked datasets from Scotland. 32 We did not see any of these type of complications in this patient series.

Safety for the healthcare personnel is a priority, and this is another reason why in our center we delay any elective procedure on a patient with a remarkable COVID-19 related history or physical exam; however, implementing a routine RT-PCR preoperative testing protocol for every procedure to prevent potential infections among healthcare personnel may be a misuse of resources and is not cost-effective. SARS-CoV-2 replicates on the epithelial cells of the upper respiratory tract, and thus the highest viral load is found in the nasopharynx, peaking 4-6 days after the onset of symptoms. Although they have found low viral RNA load in stool samples, viral RNA has not been detected in urine or blood samples. 33 Furthermore, there is a correlation between symptoms and viral load. 34 Different procedures have different relative risks of transmission: transnasal procedure may have a higher transmission risk than a breast and body contouring operation. Therefore, it may be prudent to do a preoperative RT-PCR testing for a procedure that it involves or is close to the nasopharynx or oropharynx, but not for an operation that does not involves these anatomical regions. All medical personnel should wear proper personal protective equipment (PPE) during the preoperative, intraoperative, and postoperative stages. The effectiveness of PPE among healthcare workers during the care of COVID-19 infected patients has been demonstrated. 35, 36 There was an incident in a hospital in Wuhan, were 14 healthcare workers were allegedly infected with COVID-19 after caring for a patient that underwent endonasal endoscopic surgery for a pituitary adenoma. This case was inaccurately cited multiple times for concerns for surgical personnel; consequently, the physicians involved in this case decided to publish this incident to clarify all misinformation. 36 In this case report, the author A c c e p t e d M a n u s c r i p t established that while 14 medical staff were infected during this patient's hospitalization, none of them participated in the surgery. Among the infected medical personnel included four nurses that contacted the patient directly without PPE and ten more medical staff that had no contact with the pituitary patient. Furthermore, none of the staff, including the surgeons, that contacted the patient and wore proper PPE got infected. It is important to note that patient was diagnosed with COVID-19 postoperatively; thus, it is possible that patient may have been infected after undergoing this procedure. These details underscore the importance of being objective and data driven when reporting observations and conclusions regarding COVID-19. There has been more misinformation and fake news on COVID-19 than any other medical condition.

A key limitation of our study is that it is retrospective. We also recognize that the study does not have positive (COVID-19 infected) and negative (COVID-19 non-infected) groups, but the aim was to identify the incidence of postoperative COVID-19 related complications in patients or personnel, which would include any positive COVID-19 tests if indicated based upon symptoms and national recommendations, in a cohort of patients undergoing elective surgery during this pandemic. Furthermore, would be problematic from a safety and ethics standpoint to perform elective procedures on a patient with a known, symptomatic COVID-19 diagnosis, similar as it would be to operate on a patient with a known, symptomatic influenza diagnosis. Due to our limited access to the patient's information were not able to collect datapoints (eg, ethnicity, gender, medical conditions, etc.). A multicenter review study can be considered in the future, since it can provide us with greater sample size, and thus stronger evidence. This study, however, may represent a crucial first step in that direction regarding proven patient safety undergoing elective surgery within the United States during a viral pandemic.

We found no COVID-19 related complications in a cohort of 300 patients that underwent elective procedures at an ASC using a strict preoperative screening protocol. This is further evidenced by the fact that no patients or staff studied developed viral prodromes or went on to get a COVID-19 test that resulted positive or had any postoperative complications. Careful preoperative screening and specific assessment enabled us to exclude any potential COVID-

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Table 1. Patient Demographics, Anesthesia Surgical Classification

Demographics Median age, years (range) 27 (1-90) ASA classification I: n, (%) 66 (22.0) II: n, (%) 134 (44.7) III: n, (%) 99 (33.0) IV: n, (%) , minutes (range)

A c c e p t e d M a n u s c r i p t A c c e p t e d M a n u s c r i p t