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Additional Clinical Issues and Guidance

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British Journal of Surgery Study Findings Recommend Prioritizing COVID-19 Vaccines for Surgical Patients

Posted March 30, 2021

Last week, the British Journal of Surgery released an article on a study with findings showing that prioritizing COVID-19 vaccines in patients preparing to undergo elective surgery could prevent postoperative mortality in individuals who otherwise would have contracted the virus.

According to the study, between 0.6 percent and 1.6 percent of patients having elective surgery contract COVID-19 after their procedures; as patients who develop COVID-19 are at a greatly increased risk of death 30 days following surgery, vaccinating this vulnerable population is critically important. Patients age 70 and older and patients who are receiving cancer-related surgery are particularly vulnerable to postoperative COVID-19 mortality, and administering the vaccine is even more critical in this subset.

Researchers predict that vaccinating surgical patients could save nearly 60,000 lives in one year.

Read the full study.

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AHNS Consensus Statement on Nasopharyngolaryngoscopy and Safe Clinic Reopening during COVID-19: Update from the ACS Advisory Council on Otolaryngology-Head and Neck Surgery

Posted March 30, 2021 | By Ciersten Burks, MD; Alan Workman, MD, MTR; and Greg Randolph, MD, FACS

In October 2020, the American Head and Neck Society endocrine surgery section released a consensus statement regarding nasopharyngolaryngoscopy (NPL) and otolaryngology-head and neck surgery (OHNS) clinic reopening during COVID-19. This consensus statement, developed in multidisciplinary fashion with members of the skull base, mucosal, reconstructive and salivary gland AHNS sections, outlines best practice guidelines—with the caveat that with the evolution of data regarding the disease transmission rates, testing modalities, mitigation strategies, and impact of nationwide vaccination strategies are subject to change. Five distinct recommendations were outlined in the consensus statement: defining the risks of COVID-19 in OHNS clinic, pre-visit screening and testing; environmental controls; procedure risk and source control; and engineering controls.

Defining the Risks in OHNS Clinic

Recommendation 1: The infectious transmission risk of SARS-CoV-2 in the outpatient clinic depends on a number of incompletely understood and variable factors, including geotemporal prevalence, testing type and reliability, personal protective equipment availability and efficacy, clinic procedural airborne and droplet aerosolization, and their associated clinical significance as it relates to infectivity/replicativity. Providers should remain aware of the evolving literature and adhere to local, regional and national guidance with respect to infection control.1

Coronaviruses, approximately 0.125 microns in size, are currently thought to be spread primarily via direct contact and respiratory droplets,2 with transmission via airborne aerosolization being of particular importance in relation to the OHNS provider. Notably, however, several studies evaluating health care worker infection in the setting of aerosol-generating procedures have suggested a limited period of infectivity and significant inoculum required to cause infection.3-4

Pre-Visit Screening and Testing

Recommendation 2: Pre-visit symptom and contact screening is a useful method of routing potential COVID-19-positive patients towards telemedicine visits. The interpretation of reverse transcription polymerase chain reaction (RT-PCR)-based testing remains dependent on multiple factors including false negative rate and varying community prevalence. While positive tests may be used to exclude patients from a clinic visit, negative test results should be viewed with caution and within the context of local negative predictive value rates.5

All patients should undergo symptom and contact screening within 72 hours of their visit, with confirmation screening on the day of the visit. All members of the health care team should be screened daily for symptoms. Awareness of disease prevalence within a given patient population should be maintained. Prior to NPL or rigid nasal endoscopy, COVID-19 RT-PCR testing should be considered as an adjunct to symptom screening, with caution taken regarding negative results in regions of increased disease prevalence. Several studies have confirmed that the nasopharynx is the optimal location to obtain a test sample, with the nasal cavity also considered acceptable.6,7

Environmental Controls

Recommendation 3: Clinics should adhere to CDC guidelines with regard to signage, social distancing and routine cleaning of all clinic surfaces using hospital-grade disinfectants.1

CDC and/or institutional-approved signage should be posted at strategic locations including all major entrances/exits regarding mask use, hand hygiene, cough etiquette, and so on.8 Masks should be provided to all patients upon entry. Social distancing should be maintained throughout the clinic space. All high-touch surfaces should be cleansed routinely with EPA-registered disinfectants. Health care providers must attest to daily symptoms, stay home if sick so as not to become a source of infection, and wear a mask.

Procedural Risk and Source Control

Recommendation 4: Airborne aerosol generation may occur during certain endonasal procedures. Source control masks may be used to mitigate the risk of environmental aerosol contamination but have differential efficacy with respect to droplet versus airborne aerosol protection. Providers can additionally consider high-level PPE use, including face shields and N95 respirators, when performing endonasal endoscopic procedures where airborne aerosol generation is expected.1

N95 masks should be used when performing NPL and RNE in a patient of unknown COVID-19 status. Patients can maintain some form of mask source control during these procedures to reduce the dispersion of respiratory droplets. Atomizing devices for topical anesthetics or decongestants should be avoided as they produce a significant number of aerosols; these medications alternatively can be applied without aerosolization.9

Engineering Controls

Recommendation 5: Airborne aerosol generation during OHNS procedures have the potential to contaminate enclosed clinic spaces. As infective virus may persist for prolonged periods; modifications to clinical rooms as well as room turnover to optimize ventilation, air exchange, airflow and air filtration should be considered during higher-risk procedures.1

Providers should rely on infection control experts regarding room turnover times in association with air exchange rates, filtration and ventilation pathways. Physicians may consider using discretion regarding well-tolerated NPL/RNE using source control (no sneezing, gagging, coughing, and so on) in regard to room turnover precautions.

References

  1. Bleier B, Workman A, Burks C, et al. AHNS endocrine surgery section consensus statement on nasopharyngolaryngoscopy and clinic reopening during COVID-19: How to get back to optimal safe care. Head Neck. 2021;43(2):733-738.
  2. Fehr AR, Perlman S. Coronaviruses: An overview of their replication and pathogenesis. In: Maier HJ, Bickerton E, Britton P, eds. Coronaviruses: Methods and Protocols. New York, NY: Springer New York; 2015: 1-23.
  3. Ng K, Poon BH, Kiat Puar TH, et al. COVID-19 and the Risk to Health Care Workers: A Case Report. Ann Intern Med. 2020;172(11):766-767.
  4. Cheng VC, Wong SC, Chan VW, et al. Air and environmental sampling for SARS-CoV-2 around hospitalized patients with coronavirus disease 2019 (COVID-19). Infect Control Hosp Epidemiol. June 8, 2020 [Epub ahead of print].
  5. Heinzerling A, Stuckey MJ, Scheuer T, et al. Transmission of COVID-19 to Health Care Personnel During Exposures to a Hospitalized Patient—Solano County, California, February 2020. MMWR Morb Mortal Wkly Rep. 2020;69(15):472-476.
  6. Wang X, Tan L, Wang X, et al. Comparison of nasopharyngeal and oropharyngeal swabs for SARS-CoV-2 detection in 353 patients received tests with both specimens simultaneously. Int J Infect Dis. 2020;94:107-109.
  7. Tu YP, Jennings R, Hart B, et al. Swabs Collected by Patients or Health Care Workers for SARS-CoV-2 Testing. N Engl J Med. 2020;383:494-496.
  8. Centers for Disease Control and Prevention. Interim U.S. Guidance for Risk Assessment and Public Health Management of Healthcare Personnel with Potential Exposure in a Healthcare Setting to Patients with Coronavirus Disease (COVID-19). March 11, 2021. Available at: www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-risk-assesment-hcp.html. Accessed March 25, 2020.
  9. Workman AD, Jafari A, Welling DB, et al. Airborne aerosol generation during endonasal procedures in the era of COVID-19: Risks and recommendations. Otolaryngol Head Neck Surg. 2020;163(3):465-470.

SARS-CoV-2 Vaccine Update—FDA Grants Janssen/J&J Vaccine Emergency Use Authorization

Posted March 2, 2021 | By Kenneth Sharp, MD, FACS, ACS Regent

On February 27, the U.S. Food and Drug Administration granted Janssen, the pharmaceutical company of Johnson & Johnson (J&J), emergency use authorization (EUA) for its COVID-19 vaccine. The EUA is based on released data submitted by Janssen on its 40,000+ patient study of the use of the investigational Janssen/J&J COVID-19 vaccine. This vaccine, Janssen Ad26.COV2.S, is an adenovirus vaccine—the adenovirus has been attenuated and is not capable of replicating in humans. It has been modified with an encoded variant of the SARS-CoV-2 spike protein that is expressed and elicits an immune response to the spike protein after vaccination.

The study was performed in the U.S., South Africa and extensively in Brazil and the rest of Latin America on patients 18 years of age or older. It was administered as a single intramuscular dose of 0.5 mL containing 50 billion viral particles (though a two-dose study is under way) in 39,031 patients meeting study criteria (studied patients had negative RT-PCR testing for the SARS-CoV-2 virus at the time of vaccination). Results demonstrated a 66 percent efficacy against SARS-CoV-2 infection of confirmed moderate to severe/critical COVID-19 illness. In a secondary analysis, up to 85 percent protection against severe/critical COVID-19 was observed. Additionally, hospitalizations and deaths were reduced in the vaccinated group.

The efficacy of the vaccine in some subgroups was slightly less (patients 60 years of age and older, insufficient data to analyze patients 75 years of age and older). Efficacy was slightly higher in the U.S. cohort than in South Africa or Latin America (72 percent versus 64 percent and 61 percent, respectively). Patients studied were 17.2 percent Black and 45.1 percent Hispanic/Latinx. Analysis of effectiveness in preventing asymptomatic transmission and efficacy against emerging SARS-CoV-2 variants is uncertain, but tentatively thought to be good. The safety profile was similar to prior vaccines from Pfizer/BioNTech and Moderna, with frequent minor side effects such as injection site pain, headache, myalgias and fever; very few serious side effects were noted.

Though the efficacy of the Janssen/J&J vaccine is slightly lower than vaccines from Pfizer/BioNTech and Moderna, it surpassed the 50 percent efficacy needed to obtain FDA approval of a vaccine. It has good protection against severe/critical COVID-19 illness and has two significant strengths as a vaccine compared to prior vaccines: it can be stored at refrigerator temperatures (two to eight degrees centigrade); and it is administered as a single dose. Janssen/J&J estimates it has approximately four million doses available now, with an anticipated 20 million doses by the end of March and 100 million doses available by the end of June.

CDC Updates Public Health Recommendations for Vaccinated Persons

Posted March 2, 2021

To address evolving COVID-19 recommendations for the public as more individuals receive vaccines, the CDC has updated its public health recommendations for vaccinated persons. Though there is limited information on the degree to which vaccines reduce the possibility of transmitting the virus, the CDC suggests that a fully vaccinated person who has received their last dose within the previous three months and remains asymptomatic does not need to quarantine if they are exposed to a person with COVID-19.

Read the full update.

Study Examines Impact of COVID-19 Pandemic on U.S. Adult Cardiac Surgery

Posted February 16, 2021

Since the COVID-19 pandemic began, there has been an understanding in the health care community that pauses in elective surgery, patients' uncertainty about going to the hospitals and other related factors have decreased surgical volume and likely impacted patient health. But a new study quantifies the concerns—in the COVID-19 era, there has been a substantial decline in heart surgery volume, as well as a significant increase in observed-to-expected mortality throughout the U.S.

Researchers examined data on more than 700,000 adult cardiac surgery patients and 20 million COVID-19 patients and found a 53 percent decrease in adult cardiac surgery volume nationwide, including 65 percent fewer elective procedures and 40 percent fewer nonelective procedures. During the COVID-19 era, data showed a 110 percent increase in observed-to-expected mortality for all adult cardiac procedures and an even larger 167 percent increase in mortality for coronary artery bypass grafting procedures—although surgeons note that those patients who had surgery in this period were the most urgent cases on the sickest patients, which may contribute to the increase.

According to the news release, "The abrupt cessation of surgery in mid-March 2020 has proven to have had far-reaching implications, as the negative effects of canceled and postponed procedures on patient health outcomes now are being realized."

View the article abstract, the research for which was presented at the 57th Annual Meeting of The Society of Thoracic Surgeons. Get more information on this study from a recorded press briefing from the STS.

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