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.