AO CMF International Task Force Recommendations on Best Practices for Maxillofacial Procedures During COVID-19 Pandemic

Abstract

The COVID-19 pandemic is a global problem that has adversely and significantly impacted the safe practice of maxillofacial surgery. The risk lies in the heavy viral load in the oral/nasal/upper respiratory mucosal surfaces. Surgical procedures performed in this anatomic regional produce aerosalized viral particles which are highly infectious. Best practices and recommendations are outlined to mitigate the risk to the provider.

Executive Summary

• Surgical procedures involving the nasal–oral muco- sal regions increase the risk of infection for medical personnel due to the aerosolization of SARS-CoV-2.
• Asymptomatic patients may be infected with SARS-CoV-2.
• Decisions should be taken locally, as factors vary by location; this includes incidence, prevalence, patient and staff risk factors, community needs, resource availability, and personal protective equip- ment (PPE). It is imperative to accurately determine the disease burden and curve trajectory.
• During times of potentially high incidence, elec- tive procedures and routine ambulatory visits should be canceled, until guidance is provided by government or hospital officials, and professional organizations permitting reopening for elective clinical services.
• Appropriate PPE should be worn during surgical procedures and ambulatory visits, which may include FFP2/N95 and full-face shield or controlled air-purifying respirators (CAPR) or powered air- purifying respirators (PAPR).
• Intraoperative measures which limit the generation of aerosolized particles that may harbor virus are recommended.
• Procedures (eg oncologic) in which a worse out- come is expected if surgery is delayed more than 6 weeks should be performed with appropriate PPE and testing, if available.

Background

The COVID-19 pandemic is a global problem that has adversely and significantly impacted the safe practice of maxillofacial surgery. It is important to compile informa- tion and experiences that have been gained by colleagues worldwide and define a set of best practice guidelines for staff performing, and patients undergoing, maxillofacial operations. These recommendations should be treated as “expert opinion” and are based on personal communica- tion, various national and international societies’ guide- lines, and peer-reviewed publications.

Operations involving the nasal–oral–endotracheal muco- sal region are considered high risk due to aerosolization of the virus, which is known to be in high concentration in these areas, when compared to swabs from the lower respiratory tract.[1] Further it appears that if viral particles become aero- solized, they stay in the air for at least 3 hours, if not longer.[2] Based on experience in Wuhan, China, and Northern Italy, FFP2/N95 masks were not enough to control the spread of this disease and it was not until PAPR were introduced that transmission of the virus was controlled among medical per- sonnel. It has been reported that the entire staff of an oper- ating room in Wuhan (14 people) were infected during an endoscopic transsphenoidal pituitary procedure. And there was a significant mortality of otolaryngologists and ophthal- mologists in the Wuhan region, thought to be related to exposure to aerosolized virus from the nasal and oral airway mucosa. It is important to note that this is not the common experience of most surgeons.

General Comments/Observations

Pending government and local guidance in terms of reopen- ing clinical practices, routine, elective procedures includ- ing dental should be cancelled and rescheduled when safe management strategies have been identified. Ambulatory visits should be limited to those patients requiring urgent intervention or follow-up. FFP2/N95 with eye protection or PAPR/CAPR should also be considered for urgent clinic procures. Nonurgent visits can be replaced by a telephone conversation, or videoconference if local regulations per- mit, and resources are available.

Procedures should be limited to those involving emergent airway management, epistaxis, surgical management of facial fractures which require open reduction and internal fixation (ORIF), and oncologic procedures in which a delay in management could affect ultimate outcome.

Local disease burden and community spread will ulti- mately dictate testing protocol. In the event of a lack of symptoms and virus test status, all patients should be assumed to be infected and treated accordingly. Evidence of negative COVID-19 status may be established by 2 neg- ative COVID-19 tests separated by up to 48 hours due to the possibility of false negative results. Testing of asymp- tomatic patients may not be feasible and some trauma patients will not be able to provide a history to risk stratify the patient.

Consideration should be given to limiting patient con- tact for surgeons who are over 60 years of age, are immunosuppressed, have chronic pulmonary disorders, or multiple comorbidities. The number of advanced practice providers and other medical personnel should be limited as much as possible. Proper PPE and training for all members of the team is required.

Personal Protective Equipment

There are 3 categories of PPE: standard, special, and enhanced:

• Standard PPE is a surgical cap and mask, gloves, gown, and eye protection.
• Special PPE is minimum requirement FFP2/N95 mask plus face shield or goggles (or mask with attached shield over FFP2/N95), gloves, nonporous gown, disposable surgical cap.
• Enhanced PPE is minimum requirement FFP3 mask plus face shield, gloves, nonporous gown, disposa- ble hat. Alternatively, PAPR/CAPR can be used.

If the COVID status of the patient is unknown, or cannot be determined, then Special PPE is strongly encouraged. It is generally accepted that Enhanced PPE with FFP3 or PAPR/CAPR provide better protection and should be used in place of FFP2/N95 masks if available. We realize that PAPR/CAPR may not be widely available, and other sys- tems or strategies can be used such as the helmet-based personal protection product with an FFP3 mask, or an FFP2/N95 or FFP3 mask combined with goggles and a hood. Scrubs worn during the procedure should be changed immediately afterward.

The FFP2/N95 mask is designed as a single use device. When supply is limited, the mask lifespan can be extended by at least 2 accepted sterilization processes: (1) hydrogen peroxide vapor (Battelle) or (2) UV-C irradiation (Surfa- cide). FFP2/N95 masks have been shown to tolerate 50 and 30 sterilization cycles, respectively. These systems may be available in your hospital. Additionally, a standard surgical mask may be worn as single use on top of the FFP2/N95 or FFP3 mask to avoid contamination and to provide multiple use of the FFP2/N95 or FFP3 mask.

Specific Recommendations

Operating in the naso- or oro-pharynx puts the provider at an increased risk for occupational exposure to SARS-CoV- 2 as respiratory droplets or aerosolized particles are produced that may be contaminated with SARS-CoV-2. Specific tips and suggestions are provided to mitigate this risk as much as possible. Remember that standard surgical masks are not classified as respirators and are not tested for filtering. A standard surgical mask does not provide the wearer with a reliable level of protection from inhaling smaller airborne particles and is not considered to be a respiratory protection. Only N95/FFP2, FFP3, and PAPR/ CAPR are true respirators and tested for filtering. Filtering effectiveness of a respirator is a determined value, not an estimate, which is why that it is important to be fit tested for these devices.

If the surgeon wishes to alter PPE recommendations, the occupational risk for SARS-CoV-2 exposure should guide PPE recommendations. Estimates of occupation risk are summarized in Appendix A. If the estimated risk cannot be determined or is higher than the surgeon can tolerate, then Special PPE is strongly encouraged, as Standard PPE would offer insufficient protection.

Airway Management

Intubation should be performed by the most experienced member of the team. This is not the time for multiple attempts and letting everyone have a turn. Short-term paralytic agents should be used to limit coughing. Limit the amount of mask/bag ventilation prior to intubation, and avoid jet ventilation, suctioning as little as necessary to mitigate aerosolization. Intubation is preferred over place- ment of laryngeal mask airway (LMA).

The Operating Room Team should be outside the door for 20 minutes following intubation before entering the OR. After this 20-minute delay, the team should enter with appropriate PPE (FFP2/N95 or PAPR/CAPR). The reason for this is that after an aerosol generating procedure, the virus could be present. Based on an OR air exchange rate of 20 exchanges per hour (ACH) (stan- dard for most operating rooms), 99% of pathogens should be clear in 14 minutes, and 99.9% by 21 min- utes.[3] All unnecessary personnel should be outside the room for extubation and an oxygen mask should be placed over the face after the tube is removed to miti- gate aerosolization with coughing.

Tracheotomy in COVID-19 patients is performed for similar indications to non-COVID-19 patients. Mortality in patients intubated for COVID-19 associated respiratory failure is greater than 50% and duration can be 3-6 weeks. The decision for percutaneous or open approach for the procedure is at the discretion of the surgeon. In general, in the hands of an experienced provider, an open approach may lead to less potential aerosolization, and therefore less risk. The patient should be paralyzed, preoxygenated, ven- tilation held before the trachea is incised to minimize aero- solization. Suctioning should be limited as much as possible, to avoid aerosolization. Bipolar cautery is pre- ferred over monopolar. Advance the tube distally prior to incising the trachea, to avoid creating a hole in the ETT balloon. Closed suctioning systems are preferred for tra- cheotomy care.

Highlighted recommendations from the American Acad- emy of Otolaryngology[4] include:

• Decision-making in tracheotomy should take into consideration the surgical and ICU team’s discretion as well as institutional policy.
• Avoid tracheotomy in COVID-19 positive or sus- pected patients during periods of respiratory instability or heightened ventilator dependence.
• Tracheotomy can be considered in patients with sta- ble pulmonary status but should not take place sooner than 2-3 weeks from intubation and, preferably, with negative COVID-19 testing.
• Adhere to strict donning and doffing procedures based on institutional protocol.
• Limit the number of providers participating in tracheot- omy procedure and post-procedure management.
• Perform the entire tracheotomy procedure under complete paralysis.
• Rely on cold instrumentation and avoid monopolar electrocautery.
• Advance endotracheal tube (ETT) and cuff safely below the intended tracheotomy site and hold respirations while incising trachea.
• Minimize tracheal suctioning during procedure to reduce aerosolization.
• Choose cuffed, nonfenestrated tracheotomy tube.
• Maintain cuff appropriately inflated postoperatively and attempt to avoid cuff leaks.
• Avoid circuit disconnections and suction via closed circuit.
• Place a heat moister exchanger with viral filter or a ventilator filter once the tracheotomy tube is discon- nected from mechanical ventilation.
• Delay routine postoperative tracheotomy tube changes until COVID-19 testing is negative.

CMF Trauma

Procedures should be performed by an experienced sur- geon, with a minimal number of assistants possible. In general, closed procedures, if internal fixation is not required for stability of the reduction are favored. Spe- cific recommendations follow based on the anatomical region.

Lower face/mandible fractures:

• Consider closed reduction with self-drilling Mandibular Maxillary Fixation (MMF) screws.
• Scalpel over monopolar cautery for mucosal incisions.
• Bipolar cautery for hemostasis on lowest power setting.
• Self-drilling screws for monocortical screw fixation.
• When drilling is required, limit or eliminate irrigation.
• If drilling is required, consider a battery powered low speed drill.
• If a fracture requires ORIF, consider placement of MMF screws intra-orally, then place a bio- occlusive dressing over the mouth, and use a trans cutaneous approach rather than an extended intraoral approach.
• If osteotomy is required, consider osteotome instead of power saw.

Midface Fractures

• Consider closed reduction alone if fracture is stable following reduction.
• Consider using Carroll-Girard screw for reduction, and avoid intra-oral incision, if 2-point fixation (inferior orbital rim and zygomatic-frontal (ZF)) is sufficient for stabilization.
• Scalpel over monopolar cautery for mucosal incisions.
• Avoid repeated suctioning/irrigation.
• Bipolar cautery for hemostasis on lowest power setting.
• Self-drilling screws preferred.
• If osteotomy is required, consider osteotome instead of power saw or high-speed drill.

Upper Face Fractures/Frontal Sinus Procedures

• Consider delay of nonfunctional frontal bone/sinus fractures.
• Endoscopic endonasal procedure and the associated instrumentation (power micro debriders) carry a very high risk of aerosol generation and should be avoided if possible.
• When stripping of the mucosa is necessary, minimize the use of high-speed burr or power equipment.
• Avoid repeated suctioning/irrigation.
• Bipolar cautery for hemostasis on lowest power setting.
• Self-drilling screws preferred.
• If osteotomy is required, consider osteotome instead of power saw.

Oncologic Care (International Recommendations)

If nonsurgical therapy is equivalent to surgery plus radia- tion, then nonsurgical therapy is recommended.[5,6] In addi- tion, surgery could be deferred, as recent studies have demonstrated high mortality with major surgery and peri- operative SARS-CoV-2 infection.

• Cases in which a worse outcome is expected if sur- gery is delayed more than 6 weeks, for example, squamous cell carcinoma of the oral cavity, oro- pharynx, larynx, hypopharynx.
• Cancers with impending airway compromise.
• Papillary thyroid cancer with impending airway compromise, rapidly growing, bulky disease.
• High grade or progressive salivary cancer.
• T3/T4 melanoma (see new recommendations for treatment of melanoma).
• Rapidly progressing cutaneous Squamous Cell Car- cinoma (SCC) with regional disease.
• Salvage surgery for recurrent/persistent disease.
• High grade sino-nasal malignancy without equally efficacious nonsurgical options.

Advice Concerning Dental Procedures (Adapted From AAOMS 3/17/2020)

• Emergency and urgent care should be provided in an environment appropriate to the patient’s condi- tion, and with appropriate PPE. Remember that any procedure involving the oral cavity is considered high risk.
• Asymptomatic patients requesting removal of disease-free teeth with no risk of impairment of the patient’s condition or pending treatment should defer treatment to a later date.
• Asymptomatic patients, patients under investi- gation, and patients tested positive for COVID-19, who have acute oral and maxillofa- cial infections, active oral and maxillofacial dis- ease, should be treated in facilities where all appropriate PPE, including FFP2/N95 masks, are available.
• Patients with conditions in which a delay in surgical treatment could result in impairment of their condi- tion or impairment of pending treatment (eg, impairment of the restoration of diseased tooth when another tooth that is indicated for removal prevents access to the diseased tooth) should be treated in a timely manner if possible.

This is an evolving dynamic situation, and these recommen- dations are based on the best available information currently. Please remember, these are recommendations, not mandates. The decision of the treatment of patients still rests with the individual practitioner. Our primary goal is to provide safe and effective treatments for our patients, while minimizing the risk to the practitioner and staff as much as possible.

Advice on Resumption of Elective Surgical Practice

Ultimately the ability to begin elective surgical proce- dures after easing of the pandemic is governed by local and state guidelines. Once elective procedures are allowed, being able to perform procedures safely is dependent on COVID-19 awareness in the community, health care facility preparedness, patient communication (procedure prioritization, testing requirements, etc), and ability to deliver safe high-quality care in all phases of surgical care.

14 July 2020