DISCUSSION
Italy has been the first European country suffering from COVID-19. The
unexpected spread of a scarcely-known virus was accompanied by initial
confusion and disorganization.[12] By recalling our memories and
reading the emails and text messages of the past two months, we
identified two different periods from different factors, setting March
22nd, 2020 as the turning point. During the first
month (from February 24th to March
22nd), no protection was recommended during
examinations of apparently healthy people, thus asymptomatic carriers
were not taken into consideration as possible transmission vehicles.
However, since SARS-CoV-2 is transmitted through droplets[13],
progressive evidence that Otolaryngologists are at particularly high
risk even when performing routine clinical procedures has suggested to
use surgical masks as individual protection. At that time, surgical
procedures continued to be performed wearing standard medical masks,
leaving viral-filtering-PPE available for use only in case of confirmed
COVID-19 patients. However, around the globe the shortage of PPE, along
with the lack of clear recommendations about their correct use, have
contributed to increased infections among otorhinolaryngologists. In
fact, it is noticeable that the first physician who died of COVID-19 in
Wuhan, China, on January 25th, 2020 was an ENT
surgeon, but the fact was only reported globally on March
20th, 2020.[14] More or less at the same time,
Patel et al. published a letter, which was diffused through emails and
websites, about the first case of COVID-19 transmission during an
endoscopic transsphenoidal pituitary surgery in Wuhan, that resulted in
cross-contamination of 14 healthcare workers, emphasizing the high
potential for hospital-acquired viral infections.[6,15] This has
generated reluctance to perform endonasal endoscopic procedures
worldwide. Preliminary data emerging from international laboratory and
clinical experiences show that surgical procedures involving the
airways, or using them as a surgical corridor, such as transnasal skull
base surgery, must be prudentially considered high-risk procedures, at
least until further evidence becomes available.[6,16–18] The
concurrent publication of recommendations by the Italian Society of
Otorhinolaryngology[19], the European Rhinologic Society[20] and
ENT UK[21] as well as the Italian Skull Base Society[5] led us
from March 23rd, to elevate the standard of protection
for healthcare providers during sinus and skull base procedures.
To the best of our knowledge, this is the first paper reporting the
largest case-series of patients operated for urgent and emergent sinus
and skull base pathologies during the COVID-19 pandemic in a
tertiary-care referral center.
Volume of surgical activity. A considerable reduction was
observed during the COVID-19 outbreak, as high as -60.7%. This is due
to the compliance with the Regional and Hospital provisions,
establishing elective and non-urgent surgical procedures to be
suspended. One of the aims of this paper was therefore to assess how
these provisions, together with the logistical changes imposed by the
ongoing outbreak, impacted the surgical activity of our Division.
Pathologies treated. A significant difference was found between
the two Groups analyzed (p = .016). Pairwise analysis was significant (p
= .002) when comparing malignancies with inflammatory diseases in the
two Groups, due to the high number of cancers treated during the
COVID-19 period. We believe that this is attributable to both a
reduction of the inflammatory cases treated due to suspension of
elective surgery, as well as to a reduction of the surgical activity in
other Italian sinus and skull base referral centers, which led to a
centralization of skull base malignancies cases towards our Division.
Patients’ geographical origin. The percentage of extra-regional
patients was comparable between PANDEMIC and CONTROL Groups (41.7%
versus 39.3%, respectively) without statistically significant
differences (p = .844) (Figure 1). Our Otorhinolaryngology Division is a
well-known referral-center for skull base disease, receiving many
extra-regional patients every year. Notwithstanding this unprecedented
scenario, there were several high-priority sinonasal and skull base
diseases whose treatment could not be delayed, because of the risk for
significant worsening of the patient’s quality of life and negative
impact on overall survival rates. Our preliminary results emphasize the
need for sinus and skull base referral centers able to continue
providing care even in such emergencies like the COVID-19 outbreak, in
order to manage selected critical patients at risk for a fatal course if
not treated promptly. This can be done only if the reorganization of the
referral centers, realized to face COVID-19 emergency, is able to
reserve appropriate resources for sinus and skull base surgery, namely
preserving the activity of some Departments which are essential for this
specific procedures (Neurosurgery, Interventional Radiology, Pathology,
Plastic Surgery), as well as setting up a COVID-19 free ICU for proper
postoperative monitoring.[22]
Patients’ health status. The mean follow-up time after surgery
for the PANDEMIC- Group in our study was 50 days, with a minimum of at
least 14 days, which corresponds to the estimated time of incubation for
SARS-Cov-2. All patients have been followed in the outpatient clinic by
means of endoscopic medications accordingly. At the retrospective
telephonic survey conducted on May 5th, a total 4
patients (16.7%) referred symptoms (headache and diarrhea, two cases
each) after hospital discharge and only two of them underwent
nasopharyngeal swab collection, which tested negative in both of the
cases. We acknowledge that performing a single telephone interview
retrospectively to investigate the patients’ state of health cannot
provide certainty about their health status, but it allowed us to easily
retrieve information while avoiding unnecessary or unauthorized
movements during the lockdown period.
Medical staff safeguard. Protection and health of medical staff
are a highly debated topic during the COVID-19 outbreak [6,18]. In
this regard, the initial confusion progressively faded away and the
supply of PPE became more adequate over time, so that, one month after
the beginning of the outbreak in Italy, more stringent measures for
protecting healthcare workers were adopted with widespread PPE usage and
restrictions from duty in case of suspected symptoms. Interestingly,
according to the survey performed, all symptoms referred by the
physicians serving in our Division began before the time when clear
indications were disposed by the Hospital. At present, no indication is
given to test asymptomatic medical staff for COVID-19 infection, even in
presence of epidemiologic criteria. This explains why only half of the
ENT medical staff was tested, either with a nasopharyngeal or a rapid
serological test. The latter was performed based on personal decision in
all cases. In such a critical time of resources constraints, with
stringent indications for execution of diagnostic tests, it seems
reasonable to concentrate efforts on prevention, with appropriate PPE
use and logistic re-arrangements focused on protecting the health of
both patients and healthcare workers. In this regard, our experience may
serve for the other centers who are facing sudden emergency conditions.
Open issues. To date, all
medical and nursing staff wear appropriate PPE, as prescribed in several
guidelines.[5,6] However, even establishing the aerosolization risk
of endoscopic procedures, as hypothesized by a preliminary study
performed on cadaver with detection of particles measuring less than 5
micron[17], we still don’t know exactly which procedures generate
aerosolization of mucus and possible viral particles measuring less than
0.3 micron. Therefore, although the risk for healthcare providers has
been decreased by wearing proper PPE, we still don’t know the actual
risk for non-suspect patients undergoing endoscopic transnasal surgery,
considering that COVID-19 remains viable in aerosol particles up to 3
hours.[23] Moreover, the use newer tests like the one from Abbott
(Abbott Laboratories, Chicago, IL, USA), administered shortly before
entering the patient’s operating room and results ready within 15
minutes, could impact the logistics of elective surgeries planning,
especially in the next phase of the pandemic.[24] These
considerations move us to future directions regarding the OR environment
and air turnover, how long one surgery should be distanced from the
other, and if it is necessary to change OR, always use negative pressure
ORs, use specific HEPA filters for suction or UV lights.[25–27]
Finally, neurotropism of SARS-Cov-2 is under investigation[28] and
the consequences of surgically creating a direct cerebral access route
through skull base surgeries are still unknown to date.
Study limitations. As
happens in all preliminary studies, there are some limitations to our
paper that deserve to be mentioned. First of all, it is a retrospective
study with confounding factors which were not considered in the analysis
(e.g. change of staff between 2019 and 2020, pandemic versus normal
conditions, sensitivity and specificity of diagnostic tests, etc).
Secondly, it was not possible to establish with certainty the COVID-19
status of all patients and physicians due to stringent indications to
perform nasopharyngeal swabs and/or serological tests based on current
regulations. Their widespread use would certainly strengthen the value
of this study. Thirdly, the present paper analyzed only the first two
months of the COVID-19 outbreak in Italy, which represents a reasonable
time to report an initial experience but not to draw definitive
conclusions. In this regard, it is too early to infer how the COVID-19
pandemic might influence other aspects of patients’ care, such as
long-term follow-up. Taking into account the similar situation happened
in Wuhan, we can anticipate that this will be a crucial aspect to put
efforts into during the following months.[29]
Conclusions . Although we feel optimistic for the future, we
don’t feel it is already time to restart elective surgeries, since the
pandemic, according to WHO on May 1st, 2020, is not
over yet. We believe that only urgent and non-deferrable cases should be
treated until further evidence shows adequate safety measures for both
patients and healthcare providers. Here we share our Institution’s
preliminary surgical experience aiming to facilitate the adoption of
similar measures by other referral centers. More studies and research
are necessary in order to collect data and provide more accurate
recommendations, considering that the evolution of the pandemic is
unpredictable.