MATERIALS AND METHODS
As of this writing we continue to experience the ascending portion of the COVID-19 crisis, where resources are being protected but are still available. We have not had to deny access to surgery in a way that would not meet normal standards of care, but we did have to make choices that would not have been made in normal times. We would like to share the process and approach that was used to make these decisions in three example cases, and provide a table listing 65 patients triaged over a three-week period with their diagnosis, history and disposition (Table 1).
Our system of triage evolved over this period of time, both in terms of the number of negative SARS-Cov-2 tests required to approve patients for surgery, and in terms of the emphasis on avoiding surgery. We sought to maintain current standards of care, while making adjustments based on the ascending COVID-19 crisis. The primary goal was always the well-being of the patient. If any potential harm from not proceeding immediately with surgery was not felt to be outweighed by the benefit of keeping the patient away from the hospital during the pandemic, then the surgery was performed, albeit with technical modifications to increase safety. In cases where delays were believed to have little impact, or where non-surgical therapies were thought to represent reasonable alternatives, the benefit of keeping the patient safe from viral infection or the risk of unknowingly operating during the prodrome of a COVID-19 infection,20 might be judged to tip the scales away from surgery. The public health benefits related to other patients and providers were noted but assigned lower weight.
We created a committee of six senior faculty from a department of 32 clinical otolaryngologists. This Surgical Review Committee reviewed all proposed operative cases from our university and county hospitals, nearly all of which involved head and neck tumors.
There were five stages to the triage process:
The primary surgeons evaluated their preoperative (preop) patients and made decisions with each patient regarding treatment adjustment. If a variation occurred relative to the original plan or to our standard practice, it generally was one of the following:
a. Delay of surgery for two to three months b. Transfer to a non-surgical treatment, only if that approach met normal standards of care.
c. Change in surgical approach (i.e. reduction of powered instrumentation during endoscopic transnasal resection of neoplasms).
  1. In all but the most straightforward cases, the surgeon as a next step would consult electronically with a colleague from the Surgical Review Committee. This allowed for an initial review of the case prior to the formal committee discussion.
  2. Multidisciplinary questions were taken to a Head and Neck Tumor Board (conducted virtually), where issues related to triage during the pandemic drove the discussion. Subspecialized medical and radiation oncologists participated and could confirm agreement with the plans and acceptance of patients in those cases where a shift to nonsurgical care was advised.
  3. For those cases in which the surgeon felt surgery was essential, the discussion was taken to the formal Surgical Review Committee again conducted ”virtually”. Presentation at the committee could result in suggested alterations of the surgical plan, delay of surgery, or transfer to a non-surgical approach.
  4. If the surgeon, colleagues, or committee members, felt uncomfortable with the committee recommendations, consultation with our hospital ethicists was an option. Later, if uneasiness was expressed by the patient or family, involvement of the ethicist was again considered. In fact, we consulted with individual ethicists intermittently regarding our processes and approach, but never needed to involve the formal university ethics committee regarding specific patients.
Various new standards evolved during this process. Some of these overlap with those suggested by Day et al in their recent guidelines.23 Some were uncontroversial, such as a delay of surgery for most benign diagnoses. Yet even a benign diagnosis can entail critical airway obstruction or aspiration, or other acute loss of vital function for which the window of intervention could not be extended. When MRI or CT findings suggested a more aggressive and rapidly evolving process despite a benign biopsy, clinical features and imaging took precedence. An example of this was an intranasal mass, suspected to be a benign inverted papilloma or juvenile angiofibroma, with progressive optic nerve compression and increasing vision loss. A second standard was to consider delay of surgery for slow-growing low-grade malignant tumors. Equivocal fine needle aspiration cytologic results could create uncertainty, but these situations were usually resolved by examining the clinical scenario and comparing serial imaging. In some cases, repeat biopsy or imaging was suggested, but the additional risk of more medical interventions to the patient and staff in the coronavirus setting was always weighed. Delays were justified for these more indolent malignancies, particularly if serial observation confirmed stability on physical examination and/or imaging, and if the patient had risk factors for a worse outcome with COVID-19 infection. However, given the reports of poor outcomes in healthy patients operated on during the prodrome of a COVID-19 infection 8, even healthy patients were considered at risk. A third standard was the transfer of the patient from a high-risk surgical procedure to non-surgical therapy when this represented an equivalent standard of care. The most common type of surgery for which this transition occurred was for T1 and T2 oropharyngeal cancer, with negative or early stage neck disease, where radiation with or without chemotherapy is a standard alternative treatment. Endoscopic LASER resections (Transoral LASER Microscopic Surgery or TLM), usually performed for supraglottic or glottic cancer at our institution, represented a similar category. The possibility of inhalation of smoke plume and the proximity of the surgeon to the endoscope and the patient’s oral cavity make these high-risk procedures for viral transmission in either direction. A fourth standard was that if delay or transfer to non-surgical therapy could not be justified, such as for high-grade cancers, an unsafe wound needing reconstruction, or respiratory issues, then surgery should proceed as soon as possible, but - with the exception of immediate life or death emergencies - should wait for appropriate COVID-19 testing. We quickly realized however, that even with negative testing we still needed to proceed with full personal protective equipment (PPE) especially for high risk procedures involving mucosal incisions or use of instrumentation resulting in potential aerosolization of viral particles, as testing could give a false sense of security. Initially one negative SARS-Cov-2 test was required, but early on, after Case 3 (below), this was converted to two negative test results with the last negative result within 24 hours of surgery. Apparent false negatives and false positives occasionally occurred, disrupting surgical planning and postoperative care. This is consistent with early reports from China, which report false negative rates as high as 30% in known COVID-19 patients.24 No data is available on sensitivity and specificity of routine testing of asymptomatic preop patients. We were greatly assisted by the rapid institution of reverse transcription polymerase chain reaction (RT-PCR) testing for Sars-CoV-2 by our clinical laboratories, progressing within 10 days from a test that took 3 or 4 days to produce results to one that produced results in a few hours. Quigen Rotorgene Platform using U.S. Centers for Disease Control and Prevention primer pairs and the Genmark platform were the two types of tests used. 25,26If proceeding with surgery, suggestions were often given to reduce the scope of surgery or make the surgical technique safer. For example, in one case it was thought unjustified to send an early, relatively superficial T1 supraglottic cancer in a young patient to radiation, but it was excised by cold technique instead of LASER, in order to avoid the aerosolized LASER plume. Another modification was the use of plastic covers for nasal endoscopic skull base surgery (Figure 1) along with additional suctions used to evacuate bone dust and cautery induced plumes, similar to smoke evacuators used in LASER surgery. A fifth standard was that scheduling of tracheostomy required special consideration. Tracheotomy is potentially one of the highest risk operations we perform for possible COVID-19 transmission due to the possibility of aerosolized secretions. At the same time, tracheostomy on an intubated patient may allow for weaning from the ventilator and exit from the intensive care unit (ICU), freeing the spot for another patient. Tracheostomy in a COVID-19 positive patient presents a high risk. The likelihood that tracheostomy would truly facilitate weaning for a particular patient was carefully considered, and several guidelines and publications and recommendations from our recently created departmental covid-19 tracheotomy advisory committee were seriously weighed. Our department developed institutional guidelines and protocol for tracheotomy during the pandemic based on available published national and international guidelines, taking into account the specific situation of our institution during the pandemic. Current guidelines recommend delay of tracheostomy when appropriate in the setting of acute SARS-Cov-2 infection until the patient becomes less infectious.27RESULTSFrom February 14 to April 10, 2020, we saw 129 new or suspected head and neck cancers and 83 benign tumors at our NCI designated cancer center. Suspected benign processes were all rescheduled from clinic after March 9, so the benign tumors were all seen before that. In addition, 13 new cancers were seen at our county hospital over the same period, along with 8 benign tumors. Patients needing surgery from among the patients seen at both institutions would largely have been operated on in March and April. Between March 15 and March 20, 2020, when our hospital instituted the policy forbidding ”elective” surgery, 281 otolaryngology procedures already on the surgical schedule were cancelled at the University hospital based on the initial determination by the surgeons and their coordinators that they were elective. Another 215 patients had been pending surgical scheduling in our otolaryngology department but did not yet have an assigned date. An additional smaller number of scheduled ears, nose, and throat procedures were at some point in scheduling at our county hospital and were also cancelled or not scheduled, approximately 50 cases. One hundred and eleven cases were left on the surgical schedule by otolaryngologists after March 20, for consideration as urgent. In addition, an unquantified, and probably larger group of patients were in the process of being prepared for surgery, and soon to be scheduled, and were ”self-triaged” to wait or treat non-surgically by the surgeons or by patients who were themselves concerned about coronavirus infection despite having another serious diagnosis. Thus, hundreds of patients were cut off from ”normal” head and neck surgical care. Those with urgent, mostly neoplastic diagnoses, were triaged through the processes described under ”Materials and Methods”. Table 1 lists the first 65 patients that were triaged during the initial three weeks after suspension of elective surgery. All patients who made it on to the surgical schedule during these three weeks are listed. Diagnosis, patient history, original surgical plan, and committee recommendations and disposition are included. Patients who were transferred to non-surgical care or delayed at the time of the primary surgeon’s clinic evaluation or through our tumor conference are not all included. Benign tumors without airway issues are not included unless the surgeon decided to request approval for surgery. Surgeries presenting through the Emergency Room or Trauma Unit were also not included, but transfers from other hospitals were evaluated just as outpatients would be. Our goal is to provide an overview of the process that occurred. Three unique cases are described below: