key: cord-0990389-hz3bny5l
authors: Fields, Adam C.; Vacanti, Joshua C.; Rhee, Chanu; Klompas, Michael; Kanjilal, Sanjat; Maldonado, Luisa; Robinson, Malcolm K.; Nguyen, Louis L.; Pimentel, Marc Philip T.; Doherty, Gerard M.; Bleday, Ronald
title: Restarting Essential Surgery in the Era of COVID-19: A Cautious Data Driven Approach Based on the Literature and Local Data
date: 2020-05-22
journal: Ann Surg
DOI: 10.1097/sla.0000000000004109
sha: 748439b0bb8cb5deee8bfae8bf51eba9798827df
doc_id: 990389
cord_uid: hz3bny5l

nan

O n March 11, 2020 the World Health Organization declared the coronavirus (COVID-19) outbreak a global pandemic. 1 In efforts to increase bed capacity, conserve vital medical resources, safeguard our patients, and protect frontline healthcare workers (HCWs), elective surgery across the United States came to a halt. Several states have mandated operating room (OR) closures for nonessential elective invasive procedures. 2,3 Although we have not completely passed the first wave of the virus, and there is uncertainty of how long the pandemic will last, we are now being tasked with reopening our ORs for cases that were deferred. Less urgent elective cases will need to resume too at some point because elective surgery does not mean nonessential surgery. We believe it is reasonable to start asking: how can we do this in a safe and coordinated fashion?

Even if the daily count of new COVID-19 cases continues to decline, there will still be a constant concern that any surgical patient may be harboring severe acute respiratory syndrome coronavirus 2, the virus that causes COVID-19. This is based on studies showing that some patients with COVID-19 have mild or no symptoms, and yet may be contagious or at risk for perioperative illness. As we reintroduce elective surgery, we need a new set of safety practices for providers and patients. In addition, patient selection during this period will be critical. Limited data from China have shown that outcomes of occult COVID-19 positive patients who undergo surgery are poor; 44% of patients required intensive care unit (ICU) admission and 25% died. 4 Patient selection must also consider the potential burden on hospital resources.

In this article, we will discuss how we plan to restart elective surgery in our hospital. We will review local data and published literature as the basis for our recommendations. Although these recommendations may not apply to all institutions, our goal is to inform potential strategies that other hospital systems similarly restarting elective surgery may wish to consider.

Our internal data suggest that the negative predictive value of a single nasopharyngeal polymerase chain reaction (PCR) test for COVID-19 is 99%. Our data demonstrate that only 1.3% of patients with a negative test had a subsequent test that was positive within 48 hours. However, in other geographic regions this may be higher, such as in China, where the rate was reported to be approximately 15%. 5 Within the community, the prevalence of COVID-19 in asymptomatic patients will vary by region but in general is likely around 1%. 6 Emerging data from our institution confirms this low percentage; testing of all patients admitted to our Labor and Delivery unit found 1.4% of patients tested positive while asymptomatic.

Transmissibility in asymptomatic patients is likely low except with aerosolizing-generating procedures (AGPs) or prolonged exposure to COVID-19 positive patients. In a review of contact tracing for a patient from California, 2 of 17 HCWs involved in AGPs became infected after providing care to a COVID-19 patient. 7 Moreover, in a case report from Singapore, 0 (0/35) HCWs developed infection after exposure to AGPs while wearing standard surgical masks. 8 Using these 2 studies, we estimate for the highest risk care, AGPs, that transmission risk for a COVID-19 positive patient would be 2/ (17 þ 35) or 3.8%.

One can then calculate patient/provider risk using the most conservative of estimates:

The patient risk of being COVID-19 positive and undergoing surgery would be: 0.014 (asymptomatic community rate) Â 0.15 (false negative test rate from China) ¼ 0.0021 ¼ 1:476. The risk to a provider combines the risk of a patient being positive multiplied by the risk of transmission: 0.014 Â 0.15 Â 0.038 (transmissibility rate) ¼ 0.0000798 ¼ 0.008% ¼ 1:12,500.

Our risks may be lower given our conservative estimates of all 3 assumptions. Substituting our local enterprise rate of 1.3% for patients with a negative test having a subsequent test that was positive within 48 hours, our risks would be:

Given these estimates, we propose the following interim safety practices for patients with no known COVID-19 infection being considered for surgery:

1. Asymptomatic Patients: Only patients without respiratory symptoms unexplained by concurrent illness will be offered elective surgery during the restart. If possible, surgery will be deferred for COVID-19 positive patients. We believe our community prevalence of COVID-19 is low based on our testing of asymptomatic labor and delivery patients but will confirm this in additional populations. For surgery involving the airway, N95 respirators may be worn by all personnel, although their benefit after intubation and during a procedure in a COVID-19 negative patient is not clear. Other recommendations are fluid as guidelines/community prevalence/ testing capacity change. Each hospital will need to define additional safety measures including use of enhanced PPE for non-AGPs and use of an air-exchange pause. The pause is recommended by the Centers for Disease Control and Prevention where a room has a 99% air turnover before standard precautions are used after an AGP. 4. Case selection: Analysis of our institutional data from the National Surgery Quality Improvement Program shows that the American Society of Anesthesiologists (ASA) physical status and specialty can impact which patients might need additional ventilation/ICU resources after surgery (Table 1) . ASA I-III patients for General/Neuro/Orthopedic surgery confers minimal risk of requiring specialized ventilation services while ASA III cases in Vascular/Thoracic surgery had higher risks. If ICU care is a limiting factor, this can be taken into account.

In addition to considering patient factors, some procedures are more time dependent and serious compared to others. To address these issues, we asked our surgeons to rank their procedures into 4 priorities: (1) should be done within 2 weeks, (2) should be done within 6 weeks, (3) has a critical time window, and (4) is essential but not time dependent. The priority scores were collected into an OR depot. As resources allow, the OR slots are released to the services for scheduling. As we get further from the peak of the crisis, and increase our personnel, PPE, ventilators, and hospital capacity, we will be able to expand access to additional ''lower priority'' procedures. 5. Location: We must ensure that patients admitted after surgery will be safe in our hospitals. Therefore, we recommend all asymptomatic COVID-19 negative surgery patients be co-located with other COVID-19 negative patients. We propose the following interim safety practices for patients who were previously infected with COVID-19 being considered for surgery: 

We recommend setting up a system where every patient operated on in this transition period is assessed at a standard time postoperatively for respiratory symptoms. Because the timing of an occult COVID-19 infection is usually within 5.2 days of exposure, 4 we recommend follow-up assessment 7-10 days postoperatively to gather data on the performance of our safety protocols.

As new COVID-19 cases in our hospital continue to decline, we will begin to reopen our ORs for elective surgery. Several factors must be taken into account before restarting surgery such as availability of vital resources, appropriate staffing, and new safety parameters. To protect our patients and staff, we recommend: (1) only operating on asymptomatic patients, (2) COVID-19 testing 24-48 hours before surgery and only proceeding with elective surgery if the test is negative, (3) selecting appropriate PPE for intubation/extubation for anesthesia staff depending on the community prevalence of COVID-19 and using additional PPE in some specialties performing surgery on the airway (for non-AGPs, standard precautions can be considered), (4) air exchange pause for a 99% turnover, (5) starting surgery on high priority cases and those with lower risk of requiring prolonged intubation, (6) co-locating of COVID-19 negative patients, and (7) audits of safety practices. 

Director General's Opening Remarks at the Media Briefing on COVID-19

Governor Karyn Polito. Elective Procedures Order

Continuing Temporary Suspicion and Modification of Laws Relating to the Disaster Emergency

Clinical characteristics and outcomes of patients undergoing surgeries during the incubation period of COVID-19 infection

Correlation of chest CT and RT-PCR testing in coronavirus disease 2019 (COVID-19) in China: a report of 1014 cases

Large Scale Testing of General Population in Iceland Underway

Transmission of COVID-19 to health care personnel during exposures to a hospitalized patient

COVID-19 and the risk to health care workers: a case report

Temporal dynamics in viral shedding and transmissibility of COVID-19

The duration of viral shedding of discharged patients with severe COVID-19