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).
- 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.
- 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.
- 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.
- 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: