key: cord-0845003-zzhsrytw authors: Rispoli, Rossella; Diamond, Mathew E.; Balsano, Massimo; Cappelletto, Barbara title: Spine surgery in Italy in the COVID-19 era: Proposal for assessing and responding to the regional state of emergency date: 2020-08-07 journal: World Neurosurg DOI: 10.1016/j.wneu.2020.08.001 sha: e6bc5e737a2d7ab3e0ce21113a5bacc116c1b317 doc_id: 845003 cord_uid: zzhsrytw Abstract In December 2019, coronavirus disease 2019 (COVID-19) was discovered in Wuhan, Hubei province, from where it spread rapidly across the globe. COVID-19 characteristics – elevated infectivity, rapid spread, and general population susceptibility – pose a great challenge to hospitals. Infectious disease, pulmonology, and intensive care units have been strengthened and expanded. All other specialties have been compelled to suspend or reduce clinical and elective surgical activities. The profound effects on spine surgery call for systematic approaches to optimizing the diagnosis and treatment of spinal diseases. Here, based on the experience of one Italian region, we draw an archetype for assessing the current and predicted level of stress in the health care system, with the aim of enabling hospitals to make better decisions during the pandemic. Further, we provide a framework that may help guide strategies for adapting surgical spine care to the conditions of epidemic surge. can cause the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and represents a potentially fatal disease of enormous public health importance. By the time of the World Health Organization (WHO) classification of the novel coronavirus as a global pandemic (1) , many hospitals in northern Italy were already overcrowded by COVID-19 patients, especially intensive care units, where about 50% of all available ICU beds were occupied by COVID-19 patients ( 2 ) . Physicians from specialties beyond infectious or respiratory diseases, including Neurosurgery, were reassigned to the new COVID-wards to rationalize the use of resources (3) . The COVID-19 pandemic has forced hospitals to progressively reduce surgical volume, both to minimize disease transmission within the hospital and to preserve human resources and Personal J o u r n a l P r e -p r o o f Protective Equipment (PPE) and other resources needed to care for COVID-19 patients (4) . As the COVID-19 burden on hospitals increased, Italian healthcare services responded with new procedures. These include postponing elective surgical procedures until a more appropriate time, putting in place strategies to ensure urgent/emergency operations during the pandemic, defining type of hospital and the assistance pathways, designating COVID-19 operating rooms for urgent procedures with guidance information posted conspicuously to all the professionals, ensuring systematic and correct use of appropriate PPE, controlling and limiting the number of patients' visitors, developing support strategies for healthcare professionals, and treating outpatients through telemedicine (teleorientation, telemonitoring, and teleinterconsultation) (5) . While the SARS-CoV-2 virus and its expression as COVID-19 do not appear to affect the spinal cord or peripheral nerves, except in rare cases (6, 7) , the disease impacts spine surgeons and their patients as a consequence of the overall reorganization of health care outlined above. Therefore, it is essential to formulate initiatives to help patients and healthcare professionals face this challenging situation. In the context of the pandemic, it is important to underline that most surgical spine procedures do not require intensive care (8) and the suspension of elective surgeries appears to have a relatively minor impact on ICU capacity (9) . Due to uncertainty in the future severity of the outbreak, there is no reliable timeline for the normalization of elective surgical scheduling; estimates range from several weeks to months or longer (10) . The Lombardy Regional Council, situated at the core of the Italian COVID-19 pandemic, decided to reshape the health care system by concentrating all neurosurgical activities that could not be postponed into 4 neurosurgical "hub" hospitals. Three hub hospitals guarantee 24/7 acceptance of emergency cases. The three hospitals were chosen on geographical bases; all of the other departments have been assigned to one of the three hubs as a "spoke". The fourth "hub" hospital, the regional neuro oncological center, has been re-allocated for urgent oncological patients coming from all the other departments of the region (11) . This is an example of how one regional health system, overwhelmed by the epidemic wave, reorganized the totality of its hospitals. Hospitals in Friuli Venezia Giulia (FVG) responded to the COVID-19 pandemic quickly. On March 9, the prime minister of Italy emanated the rules of a strict lockdown for all regions without J o u r n a l P r e -p r o o f distinction. To increase hospital capacity for future COVID-19 patients, the FVG health system director on March 11 limited elective surgery in general; in particular, elective spine surgery was completely suspended. Outpatient access was also reduced: thereafter, only urgent and priority B outpatients could access the medical practice. Self-sufficient patients were required to come unaccompanied. Our unit was permitted to perform only urgent spine surgical procedures such as spinal trauma and emergency spinal oncological pathology with rapidly evolving spinal cord or roots compression (12) . In the remainder of this report, we assess trends in the spread of the infection and the pressure it generates on the healthcare system, proposing a modus agendi for optimizing surgical activity. Specifically, we build a program to adapt surgical spine care to the ongoing, objectively measured stage of epidemic surge. The University Hospital of Udine is located in the immediate outskirts of Udine and is a hub Our approach is to create a scheme in which the health care authorities can rapidly assess the state of the system and provide indications to the surgery clinics in real time. We define three alert levels of the health care system -green, yellow, and red -and identify the surgical procedures appropriate to be undertaken at each level. Our view is that two readily available parameters, intensive care occupancy and the estimated doubling time of the number of infected persons, offer the means to compute the stress level of the health care system. These are plotted in Figure 1 , along with boundaries which are proposed to divide the space into green, yellow, and red alert levels. First, intensive care occupancy -the number of COVID-19 patients currently in ICU divided by the number of beds available in ICU under normal conditions -is a proxy for the current level of resources dedicated to COVID-19 patients. As the occupancy increases, from left to right along the green to yellow to red gradient, the health care system is under increasing stress and is less able to allot resources to non-COVID-19 functions. We employed ICU occupancy in the index because it is a readily accessible measure that correlates closely with overall health system stress, due to the enormous demand on personnel and materials resources associated with each single ICU patient. Figure 1 , as the doubling time decreases, from bottom to top along the green to yellow to red gradient, the health care system can expect increasing future stress and is therefore less able to allot resources to non-COVID-19 functions. To illustrate the case of the FVG region, the number of new positive cases was acquired daily from the data released by the Protezione Civile (13) . Doubling time, T d , in units of days, is where r is daily growth in percent of patients. Analyses can be easily carried out in any statistics software; for Figure 1 , we used Excel. The doubling time measure will be largely independent of regional differences in the policy or availability of COVID-19 testing. Two service areas with different testing regimes will each detect some percentage of the true carriers in their respective regions. Doubling time within both service areas will be sensitive to changes in the regional daily number of detected positives, and will accurately chart the projected spread of the virus notwithstanding differences in testing across regions. A change in testing policy or capacity within one service area will not affect the derived J o u r n a l P r e -p r o o f doubling time provided the change is effected at a slower timescale than the day-to-day count that yields the doubling time. Due to the large orders-of-magnitude ranges covered by the data, it is convenient to assess the health care system status using logarithmic scales. The alert level boundaries intersect at occupancy levels of 0.1 (green/yellow), and 1.0 (yellow/red). On the ordinate, the green/yellow alert level boundary intersects at doubling time of 1 day. The data used for each point are averaged across the previous 3 days (current date included) to smooth away daily fluctuations and to make temporal trends more reliable. In the FVG Region, the baseline count of ICU beds is 127 (14) . Occupancy of ICU beds was acquired from https://covstat.it/analisi-regioni/#trasmissione-varie-regioni (2) . Note that our scheme allows occupancy to surpass 1.0. This seemingly paradoxical situation occurs when the health system builds new ICU facilities in response to epidemic conditions, as occurred in Lombardy. When occupancy of ICU beds by COVID-19 patients is equal to or greater than 1.0, the alert level is, by definition, red. The proposed decision making grid for spine surgery, shown in Table 1 The alert level data points relative to the FVG Region of northeast Italy are shown in white points in The proposal for prioritizing surgical activities in relation to health care system alert levels is given in All these patients were admitted urgently due to the onset with neurological deficits and, in one case, for early signs of infection. As an example, we report the case of one patient with a facial and cervical trauma, with a facet fracture, on February 4. We prescribed an X-ray and re-evaluation after 3 weeks. During that period, all the non-urgent radiological exams were suspended. The patient began to experience neck pain and paresthesia. He then started to lose strength in his hands and notwithstanding the lockdown, he went to the Emergency Room. After a clinical examination, we detected signs of cord compression. X-rays and MRI showed a C4-C5 dislocation with cord compression. We operated on the young patient with a double approach. After surgery all the symptoms were resolved. During the first and second yellow alert level pandemic (7-9 March and April 21 to May 4) we performed 6 emergency surgical procedures and 1 programmed with A priority (spinal cord and\or roots impending or chronic but progressive compression, intractable pain, impending deformity). They were subdivided by etiology as follows: 3 oncologic, 3 trauma, 2 acute and 1 subacute with mechanical intractable pain, and 1 degenerative. After the return to green alert level (May 5 to 22), we performed 5 surgical procedure programmed, all with A priority. Since May 18 we have been allotted 18 hours/week to perform programmed surgery with clinical priority. In our hospital PPE (gloves, gowns, masks, etc), ventilators, ventilator filters, and medications were never lacking. The main factor that led to the reduction or cancellation of elective surgery was the availability of OR staff, who were focused on COVID-19 treatment. Clinical decisions were made and acted on prior to the formulations represented by Figure 1 and Table 1 . Retrospectively, we can observe that patients operated on during the three alert levels fell into the appropriate categories. For this reason, we can treat the 3-level decision making grid as the formalization and systematization of practices that had emerged in ipsa hora in "the heat of the battle." The ongoing COVID-19 global pandemic is unprecedented in the last 100 years. It has led to the upheaval of the health care system at all levels and in all specializations. Spine surgery triage has its own unique set of challenges and the acuity of cases may be higher than in many other surgical specialties. The spine surgeon has a crucial role to play as provider, conserver of health care resources, and public health advocate. (15) . Recently, the North American Spine Society (NASS) developed a guidance document and the authors' current recommendations for triaging surgical spine cases are largely based on this document (16) . In Lombardy the Regional Council reorganized the hospitals as described in the introduction. Oncological pathology priority has been defined as: patients requiring immediate treatment (Class A++: rapidly evolving intracranial hypertension with deteriorating state of consciousness, acute hydrocephalus, spinal cord compression with rapid tetra-or paraparesis), patients requiring treatment within a maximum of 7-10 days (Class A+: tumors with mass effect or with progressive neurological deficit, without deterioration of consciousness), patients requiring treatment within a month (Class A: oncological pathology that appears malignant and determines a neurological J o u r n a l P r e -p r o o f deficit) (17) . This was made possible with the active collaboration of the expert surgeons who developed protocols for evaluating which operations had to be done urgently and which could be delayed. In this perspective, we propose to incorporate three variables (surge level, etiology of spinal pathologies and clinical presentation) in order to create a dynamic scheme that prioritizes spine surgery. Every surgeon can apply this algorithm to any clinical scenario and place the patient in the correct box, as exemplified in Table 1 "After this pandemic, nothing will ever be the same" -this oft-heard statement is especially true for healthcare providers and surgeons. In this report have highlighted opportunities to maximize the benefit and minimize the risk of spine surgery during this pandemic and potentially, any future waves. The alert levels of Figure 1 allow us to make decisions rapidly and with a solid data base, using infection doubling time to predict the situation in the coming week. One of the benefits of the COVID-19 crisis has been the robust implementation of telemedicine and virtual visits. Although it is not meant to replace in-person medical care, telehealth allows for mitigation of patient and avoids exposure to potential contagions by facilitating compliance with home quarantine. In spine surgery, there is the potential to miss a significant neurologic deficit in the course of a telemedicine consultation; spine surgeons must increase the time spent on history acquisition and must be sensitive to descriptors suggestive of a neurological deficit. We think that at the moment telemedicine could be useful for already established patients and long-term postoperative surveillance patients. In conclusion, although there is no single universally agreed plan for recalibrating health systems in the face of the COVID-19 pandemic, we have presented a balanced and succinct description of J o u r n a l P r e -p r o o f rational, safe approaches to all surgical/clinical procedures in case of emergencies that we may encounter in the future. This dramatic, unprecedented experience teaches us to reason in terms of the scarce availability of human and material resources (beds, ventilators gloves, gowns, masks, etc.). Faced with limited resources, we are motivated to set priorities that offer the best possible care to patients with spine disease, seeking to preserve their quality of life. When we emerge from the other side of this pandemic, our hope is look back and feel confident that no patient suffered due to the unwise use of health care resources. J o u r n a l P r e -p r o o f Table 1 . Spine surgery across red/yellow/green alert levels. Relationship between clinical presentation, etiology, and alert level to guide spine surgery during COVID-19 pandemic and similar emergencies. The description of the spinal pathology is intended as an example only. 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Coronavirus NASS guidance document Neurosurgery during the COVID-19 pandemic: update from Lombardy, northern Italy Cappelletto have made substantial contributions to all of the following: (1) the conception and design of the study, or acquisition of data, or analysis and interpretation of data SARS-CoV-2: severe acute respiratory syndrome coronavirus 2 WHO: World Health Organization ICU: Intensive Care Units PPE: Personal Protective Equipment FVG: Friuli Venezia Giulia ACS: American College of Surgeons CDC: United States Centers for Disease Control and Prevention OTA: Orthopedic Trauma Association RCS