American College Of Surgeons - Inspiring Quality: Highest Standards, Better Outcomes

Previous Clinical Issues and Guidance

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. 

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.

Surgeons: Take an Active Role Promoting COVID-19 Vaccination Programs, Especially in Minority Communities

Posted January 19, 2021 | By Lisa Newman, MD, MPH, FACS, Second Vice-President, ACS, and Andre Campbell, MD, FACS, FACP, FCCM, Secretary, ACS Board of Governors Executive Committee

The ACS acknowledges the fact that the severity of the COVID-19 pandemic has been disproportionately devastating to communities of color, including minority population subsets such as African Americans, Hispanic/Latinos, and Indigenous/Native Americans. The explanation for this disparity is multifactorial and involves socioeconomic factors related to viral exposure as minorities account for a disproportionately high amount of the essential employee workforce; minorities disproportionately use public transportation; and patterns of residential segregation that result in minorities having less access to social distancing-compliant housing environments. Compounding these issues, the COVID-19 economic recession has also affected minorities disproportionately; these communities have experienced higher unemployment rates and loss of employee-based health insurance compared to white Americans.

COVID-19 vaccination programs represent an opportunity to interrupt the cascade of factors that contribute to the progressively adverse impact of the pandemic on the health of minorities. Tragically, though, myriad factors related to systemic racism in health care have created substantial barriers to implementing these vaccination programs in the very communities that have the greatest need. Neighborhoods that hold communities of color are more likely to be "pharmacy deserts," which will impair access to the vaccine. Safety net hospitals and clinics have suffered disproportionately from the economic toll of COVID-19 care, with many of these facilities having limited resources to provide vaccinations on a large scale. Lastly, well-documented historical abuses of minorities in medical research have resulted in a legacy of mistrust among our patients, resulting in widespread misinformation regarding potential harms from vaccination.

The College recommends that surgeons play an active role in promoting COVID-19 vaccination programs for our diverse patient population to protect all patients and help stop the spread of COVID-19. We furthermore encourage our members to participate in activities that will expand awareness of vaccination safety and vaccination access among our patients belonging to minority race/ethnicities. Examples of such activities include the following:

  • Be a role model and speak freely regarding your personal vaccination experience.
  • Many patient advocacy and community outreach groups are specifically organized to serve minority population subsets, such as those that provide screening for cancer, diabetes and hypertension. Leverage relationships with these networks to disseminate information regarding the safety of vaccination and the fact that its development was spearheaded by a diverse group of scientists, such as African-American virologist Kizzmekia S. Corbett, PhD.
  • Share information regarding vaccination safety with community-based organizations, civic associations and churches that have strong minority memberships.
  • Monitor ongoing safety updates regarding COVID-19 vaccines and proactively share the latest developments with patients to ensure transparency and preserve trust.
  • Encourage your hospital leadership to develop vaccination outreach programs that will reach minority communities.
  • Encourage your hospital leadership to promote vaccination awareness and access among diverse personnel.

Strengthened ties between surgeons and our diverse patient population about how COVID-19 vaccination represents a powerful strategy in curbing the pandemic, and these improved community relations will serve as a foundation for achieving overall health equity in the future.

ASA and Anesthesia Patient Safety Foundation Issue Statement on Timing for Operating on Recovered COVID-19 Patients

Posted January 19, 2021

With more than 24 million Americans diagnosed with COVID-19 and most eventually recovering, hospitals are being increasingly faced with the need to operate on recovered COVID-19 patients, which can present unique perioperative challenges. To aid in the decision-making process for scheduling and evaluating recovered COVID-19 patients for surgery, the American Society of Anesthesiologists and the Anesthesia Patient Safety Foundation in December 2020 released a joint statement containing guidelines for surgery.

The statement describes determining factors for when a confirmed COVID-19 patient is no longer infectious, the appropriate length of time between recovery from COVID-19 and surgery to minimize postoperative complications, and whether repeat COVID-19 testing is necessary. Generally, "all nonurgent procedures should be delayed until the patient has met criteria for discontinuing isolation and COVID-19 transmission precautions and has entered the recovery phase. Elective surgeries should be performed for patients who have recovered from COVID-19 infection only when the anesthesiologist and surgeon or proceduralist agree jointly to proceed," the statement reads.

Read the full joint statement.

Update on Antibody Therapies for COVID-19

Posted January 12, 2021 | By Kenneth W. Sharp, MD, FACS, ACS Regent

Recently, U.S. Health and Human Services Secretary Alex Azar has discussed the effectiveness and encouraged the use of monoclonal antibody therapy as a tool to prevent severe disease or disease progression in patients over the age of 65 or at risk for severe disease.

At present, there are three approaches to the use of antibodies for preventing or reducing the severity of COVID-19. There are two commercially available monoclonal antibody preparations: Eli Lilly's LY-CoV555 and Regeneron's REGN-COV2. There also is increasingly positive data from the use of high-titer convalescent plasma for the same purpose.

The Regeneron monoclonal antibody (REGN-COV2) preparation, notably used in the treatment of President Trump, is a combination of two human neutralizing monoclonal antibodies against the SARS-COV-2 spike protein. A combination of two non-competing antibodies is used because of concerns about the emergence of resistant mutations in the virus, which previously has been a problem with monoclonal antibodies used to treat respiratory syncytial virus (and may be topical now as viral mutations in SARS-COV-2 are becoming an important challenge). A recently published phase 1–3 trial included 275 patients with documented SARS-COV-2 infection who were treated with a single infusion of high-dose or low-dose REGN-COV2 or placebo as outpatients within seven days of symptom onset. The treated patients had substantially reduced viral loads at day seven and had fewer "medically attended" follow-up visits for increasing symptoms, indicating a reduction in symptoms. Minimal adverse side effects were noted.

The Eli Lilly preparation, LY-CoV555, recently has been shown to have similar effects in reducing viral load in mildly symptomatic outpatients with COVID-19 who had at least one risk factor for developing severe disease (age > 65, BMI > 35 or a relevant coexisting illness) and also reducing symptom severity. It also is administered as a one-hour infusion of a single dose within a median duration of four days of symptoms. Importantly, the need for hospitalization was reduced from 6.3 percent in the placebo group to 1.6 percent in the treated group. No serious adverse side effects were reported.

The use of convalescent plasma has been previously covered in the Bulletin Brief but a recently published NEJM article about the use of high-titerconvalescent plasmaearly in the course of COVID-19 significantly reduced the progression to severe disease. This Brazilian trial enrolled 160 outpatients who were either older than age 75 or between the ages of 65 and 74 with at least one high-risk coexisting disease and who were randomized to treatment with 250 ml of a high-titer dose of convalescent plasma or with placebo. Infusions lasted 1.5–2 hours and were administered within 72 hours of the onset of symptoms. Severe respiratory disease developed in 12 percent of the treated group and 29 percent in the placebo group. No serious adverse side effects were reported.

The use of these biologic agents seems to show a beneficial effect for patients at risk for developing severe disease when treated early in the course of COVID-19. Previous results when given to severely ill, hospitalized or ventilated patients did not show conclusively beneficial results.

The slow adoption of these treatments likely is multifactorial. Barriers to use of these agents include the need to rapidly identify high-risk patients early in the course of the illness, which implies rapid testing; the need for intravenous infusions and the attendant personnel and facility needs balanced against the surge of hospitalized COVID-19 patients needing huge numbers of personnel; scarce hospital facilities; and the expense of the treatments. Additionally, an additional factor to assess is the balance of needing to treat numerous patients vs. avoiding hospitalizations in a much smaller number of patients. These studies of high-risk patients obviously are targeted to a population that is more likely to need hospitalizations, so assessing the need for use in lower-risk patients is problematic.

Chapters in Focus: Activities of the ACS Argentina Chapter during the COVID-19 Pandemic

Posted January 12, 2021

Due to the restrictions imposed by the COVID-19 pandemic, the ACS Argentina Chapter (ACS-AC) was forced to find new modalities to maintain its usual academic activities. The keystone academic activity is our Annual Meeting, hosted during the National Surgical Meeting in partnership with the Argentine Surgical Association. However, because the meeting was deferred to November 2021, the group encountered the following challenges in trying to maintain an educational presence in a new online platform:

  • The cost of a virtual platform that allowed concurrent sessions
  • The difficulty of gathering all sessions consecutively in one or two days
  • The lack of simultaneous translation from English to Spanish

Creating Interest

Much discussion arose about the potential success of organizing a series of web-based sessions with invited speakers. It was agreed to start with a keynote speaker and Past-President of the College, Carlos Pellegrini, MD, FACS, FRCSI(Hon), FRCS(Hon), FRCSEd(Hon). He is widely recognized in Latin America and could deliver his talk in Spanish, and his presence could help us reach a wide audience. His lecture, Tips for Young and Not So Young Surgeons: How to Overcome Adversity, was an attention-grabber and generated widespread interest. Lecture attendance was huge and the impact so great that an immediate decision was made to continue with this educational offering, as well as to keep the schedule of Tuesdays at 7:00 pm for our webinars. The lectures were delivered via the Zoom platform, generously supported by the University of Buenos Aires "Jose de San Martín" Hospital Medical Association.

Two topics were tackled: Emergency and Trauma Surgery and Hepato-Pancreato-Biliary Surgery. The search for guest speakers followed. We maintained the practice of hosting a Spanish-speaking guest and not more than two speakers at each session. We reached out to department chairs, program directors and all surgeon members of our chapter, the Argentine Surgical Association and the Argentine Surgical Academy, as well as regional and international surgical associations. Social media and WhatsApp communications were an effective way to deliver and disseminate our programs.

Diverse Session Topics, Expert Surgeon Presenters

The first session of the Emergency and Trauma Surgery webinar included Juan Puyana, MD, FACS (Pittsburgh University), and Paula Ferrada, MD, FACS (Virginia Commonwealth University). The guests for the second event were William Sánchez, MD, FACS (Bogotá, Colombia), and Jorge Neira, MD (Argentina), Executive Director of the Trauma Foundation. The third session featured Esteban Foianini, MD, FACS (Bolivia), and Jamal Hoballah, MD, MBA, FACS (Lebanon). Professor Hoballah was chosen based on his amazing lecture sponsored by the ACS International Relations Committee, and we judged that our audience would welcome his report of his experience in the Port of Beirut explosion. Because of the time difference, his lecture was recorded earlier, for later broadcast. The fourth and closing session was in the hands of Juan Asensio, MD, FACS, FCCM, FRCSEng, (Creighton University), well-known in Argentina and Latin America, and the guest moderator was Julio Trotchansky, MD (Uruguay). The module was a complete success; each session drew an audience of more than 150 participants from Argentina and Latin American countries.

The second series was devoted to the topic of HPB Surgery, and the decision was to open the webinar with an inspiring figure: Andrew Warshaw, MD, FACS, FRCSEd(Hon), whose lecture on Progress and Perspectives for Surgery of Pancreatic Cancer attracted more than 180 attendees. Other invited guests  were Carlos Fernández del Castillo, MD, and Cristina Ferrone, MD, FACS, both from Massachusetts General Hospital/ Harvard Medical School; Xabier de Aretxabala, MD (Chile); and Eduardo Montalvo Jare, MD (México). The final session was organized in partnership with the Cleveland Clinic Foundation and featured Matthew Walsh, MD, FACS, and Federico Aucejo, MD. All the invited speakers were convened based on the personal recommendation of Prof. Alberto Ferreres, MD, PhD, MPH, FACS, Argentina Chapter Governor.

In summary, the Argentine Chapter increased its visibility, proved the benefit and utility of a web-based educational program and contributed to promoting the educational role of the College and professionalism inspired by the College leaders. Our idea is to continue with our educational offering in March with sessions featuring the University of Colorado department of surgery (Richard Schulick, MD, FACS, and Marco del Chiaro, MD, PhD, FACS), and another in partnership with the Italy Chapter.

ACS Review and Recommendations on the SARS-CoV-2 Vaccine

Posted December 15, 2020

The Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Pfizer/BioNTech's mRNA vaccine against the SARS-CoV-2 virus. The FDA's Vaccines and Related Biological Products Advisory Committee voted on Thursday, December 10, to recommend the FDA issue an EUA, following extensive review of safety and efficacy data on the Pfizer/BioNTech vaccine. The clinical trials of the vaccine included more than 40,000 participants—all over the age of 16—and found high vaccine efficacy in all age groups, genders, races, ethnicity and participants with the presence of comorbidities. Access the FDA briefing materials that provide a comprehensive overview of the safety and efficacy data.

The ACS has reviewed the safety and efficacy data submitted by Pfizer/BioNTech and strongly encourages surgeons to take the vaccine when available to them. Mild systemic side effects are very common with this two-dose vaccine (fatigue, injection site reactions, and fever) but serious adverse side effects were very rare. Doses will be dispensed to individual states, which will control local distribution.

Prepared by Kenneth W. Sharp, MD, FACS, on behalf of the American College of Surgeons Board of Regents

A Renewed Focus on Early Onset Colorectal Cancer and Screening

Posted December 15, 2020 | By the ACS Advisory Council for Colon and Rectal Surgery

Screening for colorectal cancer is performed through stool-based tests, imaging (such as CT colonography) or endoscopy. The latter, colonoscopy, is considered the "gold standard," offering the ability to both diagnose lesions at an early stage, as well as treat premalignant lesions endoscopically and thereby prevent cancer. Recent changes in the American Cancer Society Guideline for Colorectal Cancer Screening have recommended starting routine screening for average-risk patients at age 45, down from the previously recommended age of 50 (read the updated American Cancer Society guidelines). The U.S. Preventive Services Task Force, which in 2016 had recommended to begin screening at age 50 for average-risk individuals, also more recently released draft guidelines recommending lowering the age to 45 for this same group (read the USPSTF update).

These changes were in direct response to the increase in incidence of early age onset colorectal cancer. Yet, colorectal cancer remains the second or third leading cause of cancer-related death each year in the U.S. While colorectal cancer incidence and death rates have seen a decrease over the last few decades—in part due to awareness and screening strategies—the recent death of actor Chadwick Boseman, of Marvel Comic's Black Panther, has drawn further public attention to the rising incidence of colorectal cancer in adults under the age of 50. According to the National Cancer Institute, since 1994, cases of early-onset colorectal cancer have increased by 51 percent.

While a cancer diagnosis at any age calls for expert treatment, young patients with colorectal cancer often have diagnostic and treatment considerations that are specific to their early age of onset. David Liska, MD, director of Cleveland Clinic's Sanford R. Weiss, MD Center for Hereditary Colorectal Neoplasia, has established an Early Onset Colorectal Cancer Center with the aim of providing young colorectal cancer patients with personalized, comprehensive and coordinated world-class care. "Along with other institutions in the United States, we recognize the need for a multidisciplinary team that understands that young adults with colorectal cancer face unique issues that require expert support at the time of diagnosis, during treatment, and during the survivorship and surveillance phase," Dr. Liska said.

Composed of providers with renowned expertise in surgery, oncology, radiation therapy, genetics, gastroenterology, oncofertility, psychology and lifestyle medicine, the center aims to design a personalized care plan with a focus on curing cancer and maximizing survival, while also assuring optimal quality-of-life for patients whose cancer diagnosis can interrupt their most productive years. By bringing together a team of experts, the hope is to also stimulate groundbreaking molecular and clinical research to better understand the etiology underlying the alarming rise in early onset colorectal cancer, with the goal of developing novel treatments and risk-based screening recommendations.

The renewed focus on expanding screening for colorectal cancer also is a reminder that even in the setting of a pandemic such as COVID-19, with its associated challenges, there is a tremendous need to continue with important baseline health maintenance screening examinations like colonoscopy.

Orthopedic Surgery—Levels of Urgency for Orthopaedic Procedures: Reliability and Adoption of a Consensus-driven Classification

Posted December 11, 2020 | Published in Journal of the American Academy of Orthopaedic Surgeons

The authors write that, “An orthopaedic surgery-specific prioritization schema [during COVID-19] with proven reliability is lacking. The primary aim of this study was to assess the reliability of a newly developed prioritization list used for the phased reinstatement of orthopaedic surgical procedures during the COVID-19 pandemic.” Read the article.

Vascular Surgery in the COVID-19 Era: An ACS Advisory Council Report

Posted October 20, 2020 | by Audra A. Duncan, MD, FACS, FRCSC, Chair, ACS Advisory Council for Vascular Surgery

The COVID-19 pandemic has impacted health care outcomes and delivery in every specialty, and vascular surgery is no exception. Many vascular surgery patients are frail, elderly, have multiple co-morbidities and may be residents of long-term care facilities—all factors adding to the risk of acquiring COVID or having a poor outcome from COVID infection. Many older patients who shelter-in-place may avoid seeking care for symptomatic vascular disease, resulting in increased complications due to delays in care. Internationally, hospitals have postponed or canceled elective and semi-urgent procedures to increase hospital beds for COVID patients. Additionally, we now know that COVID patients can develop vascular thrombotic complications, including acute limb ischemia, acute mesenteric ischemia, venous thromboembolism and stroke.

To address both the impact of COVID-19 on scheduled vascular operations and the thrombotic complications of COVID-19, the Vascular Surgery COVID-19 Collaborative was developed to accrue data from international institutions. The VASCC group has received further cooperation from the Vascular Low Frequency Disease Consortium (VLFDC). This international initiative can not only help identify patterns of health care and patient outcomes in vascular surgery during COVID but ideally it will help identify future methods of managing patients during pandemic or global crises.

For more information on VASCC, see the following:

Do the Eyes Have It? Update from ACS Advisory Council for Ophthalmic Surgery on COVID-19 Impact

Posted October 13, 2020

We are all still trying to come to grips with COVID-19 and to make short-term and long-term plans—it would be nice to know if a second or third wave will activate our contingencies.

In the meantime, ophthalmologists are discerning the best way to safely see patients. Ophthalmologists may be at higher risk of contracting the virus because of close exposure to the eyes, nose, and mouths of patients. Like head and neck surgery, ophthalmic oculofacial specialists work in the periorbital nose and sinuses. The American Academy of Ophthalmology notes 16 COVID-related deaths of ophthalmologists, with three from the U.S.

Ophthalmology is typically practiced in high-volume outpatient settings; a busy office can see 100 patients a day. For the foreseeable future, given the required infection control measures, this volume is likely unattainable. We are working on ways to maintain throughput while social distancing and to keep our patients and employees safe. Some of these new ideas will likely pay dividends down the road, making our practices better in the long run. The AAO and American Society of Ophthalmic Plastic and Reconstructive Surgery organizations have developed thoughtful guidelines to assist in these efforts.

Staying on Course during COVID-19: Spine Services in India

Posted September 8, 2020 | Advisory Council for Orthopaedic Surgery

With a population dividend of 1.3 billion, establishing quality health care is an uphill task. However, health care in a tropical country like India is highly recognized but largely unorganized. Amid the emergence and spread of the COVID-19 pandemic, India’s health care system faces a new challenge. Health care personnel, including surgeons, are particularly at risk because of close proximity to infected patients. During this period, the deluge of COVID-19 patients and overcrowding in hospitals has put immense strain on health care facilities and professionals.

All India Institute of Medical Sciences, New Delhi, a premier institute of health sciences, is known for its excellence in teaching, training, research and patient care. New Delhi, a capital of India, shares a unique geography and diversity that represents a Pan-Indian culture and therefore represents an opportunity to restore high standards during a public health emergency that brings both challenges and opportunities. Therefore, it is imperative to build a robust and agile health care system that can work substantially over a period of time until a vaccine is available.

While optimizing the routine hospital care services, particularly at an apex institute like AIIMS, presented a great challenge because many hospital resources were shifted toward COVID-19 management. We had to both formulate new policies and carry on with given mandates of the institute. At the very beginning of this crisis, AIIMS compartmentalized its resources to handle the situation. Revival strategies during the COVID-19 era encompass teaching, research and patient care, and much of the work has been routed through technological interventions from distant mode and communication centers for ensuring uninterrupted flow of information among health care providers.

The major steps taken by our institute in a phased manner include:

Major Initiatives

  • Formulation of guidelines to COVID-19 management
  • Creation of a task force for COVID-19 management
  • Continuation of general emergency and casualty services
  • A declaration that AIIMS’ two major centers, including trauma centers (JPNTC, New Delhi) and cancer institute (Jhajjar, HR), would serve as dedicated COVID-19 centers
  • Start-up of telemedicine services with all disciplines to provide teleconsultation for follow-up care
  • Provision of personal protective equipment and safety measures to all health care workers
  • Publicity through news bulletins in public domain on COVID-19 updates
  • Large-scale COVID-19 antigen and antibody testing by biochemistry and microbiology departments
  • Performance of urgent operations
  • Maximize safety for admitted/in-house patients

Services Pertaining to Orthopaedics Discipline and Spine Research Unit

Although it was not possible to perform nonurgent operations during the nationwide lockdown, spine services within orthopaedics discipline have carried on in accordance with the given guidelines.

  • With the use of telemedicine services, teleconsultation was available to patients and surgeons still performing spine operations in other centers.
  • Emergency operations were performed.
  • Spine research unit published more than 20 research articles in high-impact journals.

Needless to say, we need  to build a viable framework and a road map for academicians, researchers, and health care professionals to arrive at the best possible solutions and outcomes.

Progress Made in Using Convalescent Plasma to Treat COVID-19 Patients

Posted August 25, 2020

The U.S. Food and Drug Administration (FDA) announced Sunday that it issued an Emergency Use Authorization (EUA) to permit the emergency use of COVID-19 convalescent plasma to treat hospitalized patients with COVID-19. Interest in the use of convalescent plasma to treat COVID-19 has been high since the early phases of the pandemic, and while some prominent members of the scientific community are enthusiastic about its use, others are more cautious.

Interest in the use of convalescent plasma to treat COVID-19 was rooted in previous promising experiences with using plasma to treat other viral pandemics and epidemics, including the 1918 influenza, the H1N1 influenza in 2009 and severe acute respiratory syndrome and Middle East respiratory syndrome (both coronaviruses) in the last two decades. An excellent short history and proposal for the development and use of convalescent plasma (sera) was published in early March by Casadevall and Pirofski.

The use of sera is based upon the donation of plasma from patients who have recovered from documented COVID-19 illness. Neutralizing antibodies should be present in this plasma, but concentration varies from none-to-low titers to high titers. Previous experience suggests that high-titer sera are more effective than plasma with low titers (lower concentrations) of neutralizing antibodies.

Early experiences in transfusing severely ill patients with COVID-19 in a small series were published in March and April. These studies showed the promising effects of the use of convalescent plasma but were uncontrolled and not blinded.

One of the first randomized trials of the use of convalescent plasma in COVID-19 treatment was published in June and failed to show a significant improvement over standard treatment without the use of convalescent plasma in patients with severe or life-threatening disease. The trial was suspended prior to planned full enrollment, as the incidence of disease in this study from China declined precipitously as the pandemic waned in many parts of the world. Subgroup analysis, however, showed that patients who were severely ill had better outcomes than patients with life-threatening illness, giving some promise and potential guidance to treating patients earlier in the disease course.

Experience with the use of convalescent plasma grew in the U.S. as the pandemic continued. Data from an expanded access program (EAP) developed in conjunction with the FDA, the Mayo Clinic, and the national blood bank community showed the safety of the use of convalescent plasma in the first 5,000 patients in June. The incidence of serious adverse events was less than 1 percent, and few of these complications could be linked directly to the plasma transfusion. Mortality was noted to be low in treated patients, but the study was not designed to be controlled or randomized, so no inference could be made to show a definite beneficial effect of the plasma.

One of the first controlled prospective propensity score matched trials (not a randomized controlled trial) in the use of convalescent plasma was reported earlier this month. Houston Methodist Hospitals reported on 136 patients transfused with convalescent plasma versus 251 non-transfused patients. Mortality declined significantly in patients with severe or life-threatening disease who received high-titer convalescent plasma within 72 hours of hospital admission.

A pre-peer-reviewed article in July reviewed data from 12 worldwide studies (three randomized clinical trials, five matched-control studies and four case series studies) and concluded that patients treated with convalescent plasma experienced reduced mortality rates compared with patients who received standard treatment.

The most recent and largest study of the use of convalescent plasma has been released as a pre-peer-reviewed manuscript. This study extracted data from a large EAP and looked at outcomes for 35,322 transfused patients receiving convalescent plasma April 4 to July 4. Investigators found that patients transfused within three days of diagnosis were significantly more likely to survive at seven days and at 28 days than patients transfused four or more days after diagnosis. In addition, patients transfused with high IgG plasma were more likely to survive than those receiving low IgG plasma—confirming a dose response relationship that would be expected. It should be noted that this study is a retrospective analysis of data collected in a large group analysis, not a randomized controlled trial.

The most recent response to this data was reported in the New York Times August 19—just days before the FDA released its authorization for the emergency use of convalescent plasma for patients with COVID-19. Concern exists that the EAP has grown so rapidly (the Mayo group database now includes more than 66,000 cases involving transfusion of convalescent plasma) that it may become difficult to perform standard randomized controlled trials because patients and physicians may refuse to accept the possibility of receiving placebo rather than convalescent plasma. We will continue to track and share updates as they are available.

Joint Statement Addresses Rescheduling Operations in Areas Experiencing a Resurgence in COVID-19 Cases

Posted August 18, 2020

The American College of Surgeons, American Society of Anesthesiologists, Association of periOperative Registered Nurses and American Hospital Association issued a joint statement August 10 for maintaining essential surgery during the COVID-19 pandemic. The roadmap responds to the resurgence in COVID-19 cases that is occurring in many parts of the U.S., resulting in hospitals that are near or at bed and intensive care unit capacity. The joint statement notes that health care facilities, physicians and nurses must remain prepared to meet the demands for patients hospitalized with COVID-19 and for patients in need of essential surgery services. It reiterates a list of principles and considerations to guide physicians, nurses and local facilities in their care in ORs and all procedural areas during the ongoing pandemic, including the following:

  • Regional cooperation to ensure access to essential surgical services
  • Collaboration among hospitals, medical professional societies and government to ensure adequate supplies of vital equipment and medications
  • Use of available testing to protect staff and patient safety as well as implementation of policies that address requirements and frequency for patient and staff testing in accordance with current Centers for Disease Control and Prevention guidelines
  • Rescheduling of nonemergent essential operations unless the facility has adequate personal protective equipment and surgical supplies
  • Establishment of a prioritization policy committee consisting of surgeons, anesthesia professionals and nursing leadership
  • Adoption of policies across the five phases of surgical care that address care issues specific to COVID-19 and the postponement of operations
  • Application of procedures to reevaluate and reassess policies and procedures frequently, based on COVID-19-related data, resources, testing and other clinical information

Delays in Surgery Do Not Appear to Affect Overall Survival for Early-Stage Breast Cancer Patients

Posted August 11, 2020

study published in the Journal of the American College of Surgeons shows that surgeons who provide care to women with early-stage breast cancer and who have had to delay operations because of the coronavirus disease 2019 (COVID-19) pandemic can rest a little easier. During the COVID-19 pandemic, surgical delays have been common for patients with ductal carcinoma in situ and early-stage estrogen receptor-positive breast cancer, often in favor of neoadjuvant endocrine therapy. To understand the possible ramifications of these delays, the authors examined the association between time to surgery, pathological staging and overall survival.

The researchers conducted this study using the National Cancer Database and analyzed data for 378,839 patients with early-stage breast cancer in 2010−2016. Patients were divided into two groups: one cohort had ductal carcinoma in situ; the other group had small invasive tumors—stage I and limited stage II—that had not spread to nearby lymph nodes and were estrogen receptor-positive. The researchers evaluated whether longer time to surgical treatment up to one year after diagnosis had an association with final pathologic staging of the cancer or with five-year overall survival.

Among patients who underwent primary surgery, the operations were performed within 120 days in more than 98 percent of all groups. Among cT1-2N0 patients selected for NET, surgery was performed within 120 days in 59.6 percent of cT1N0 and 30.9 percent of cT2N0 patients. Delays in operative care were associated with increased odds of pathological upstaging in DCIS patients, but not in patients with invasive cancer, regardless of initial treatment strategy. No difference in overall survival OS was detected in DCIS or NET patients who experienced delays in surgery.

The authors conclude that delays in surgery was associated with a small increase in pathological upstaging in DCIS patients, but did not impact OS. In patients with cT1-2N0 disease, NET use did not affect stage or OS, supporting the safety of delay strategies in ER-positive breast cancer patients during the pandemic.

3-D Printing Is Key to Global Improvements in Care: An Update from the ACS Advisory Council for Oral-Maxillofacial Surgery

Posted August 4, 2020

The use of 3-D printing has grown exponentially in oral-maxillofacial surgery worldwide. It is becoming commonplace for practices to use in-house 3-D printing capability to assist in the reconstruction of trauma, cleft and craniofacial, pathologic, and dentofacial anomalies, assisting in fabrication of study models, surgical guides, and dental prostheses. Through point-of-care 3-D printing, head and neck reconstructive surgeons and oral-maxillofacial surgeons can now perform dental implant-retained restorations for immediate placement at the time of fibula reconstruction for oncology patients. Throughout the COVID-19 pandemic, oral-maxillofacial surgery programs have put their printers to work to fabricate nasopharyngeal swabs and shore up the shortage in testing materials. Details have been published here.

The Race for a COVID-19 Vaccine: A Sprint or a Marathon?

Posted August 4, 2020

The race to develop a safe and effective vaccine against severe acute respiratory syndrome coronavirus, commonly known as COVID-19, is one of the most important public health issues facing the world today. To achieve herd immunity and thereby reduce the risk of COVID-19, it is estimated that immunity rates of 60 percent or more are needed, and achieving these rates of immunity without an effective vaccine would impute deaths of millions of people after infection through normal transmission paths.

An article in Nature illustrates and reviews the vaccine basics. Four basic types of vaccines have been proposed—intact virus, viral vectors, nucleic acid (DNA/RNA) and protein-based. Intact viral vaccines, such as those that protect against measles and polio, are made from inactivated or weakened viral strains. Viral vector vaccines, including the Ebola vaccine, are derived from genetically engineered weakened viruses that produce coronavirus proteins to raise an immune response. DNA/RNA vaccines use nucleic acid insertion into human cells that encode viral proteins that provoke host immune response. They are easy to engineer and develop but are unproven, and no licensed vaccines are made this way. Protein-based vaccines work by infusing various viral proteins (mostly against the spike protein) to elicit an immune response.

The first stage of validating proposed vaccines is in small studies of healthy and usually young volunteers. A Phase 1 trial of SAR-Co-V2 vaccines and commentary have been published in the New England Journal of Medicine.

Phase 1 trials are done to determine the effectiveness of escalating as measured by antibody response and to determine incidence of side effects in a small number of recipients. Publicly announced vaccine candidates that are being developed at “warp speed” are covered in JAMA.

Phase 2 trials are larger, often include very young and very old patients and are intended as much larger trials of safety and antibody response. Large trials are needed to investigate the true effectiveness in reducing infection with SARS-CoV-2 in a large population exposed to the larger populations with endemic or epidemic rates of infection. These trials are now being announced in the press and are “of the minute”; that is, starting or near starting to accrue volunteers.

Paradoxically, it is easiest to validate effectiveness of a vaccine with a growing or high level of prevalence of the infection, so the high rates of infection currently found in southern and western states may enable quicker validation of vaccine utility. Of note, many tentative or proposed therapeutic drug trials planned in China during the early stages of the pandemic had to be halted as the disease incidence dropped dramatically, as quarantine and other measures slowed and stopped SARS-CoV-2 infection by late spring. Concern for the speed with which a vaccine could be developed has thus led to discussion of challenge trials of vaccines—administering a vaccine to healthy volunteers and then challenging them with an infectious dose of SARS-CoV-2 virus to see if the vaccine truly confers immunity. This approach is controversial ethically, and has strong proponents and opponents.

Vaccine development against COVID-19 disease is moving at the most rapid pace in the history of vaccine development. Historically, vaccine development has been a three- to six-year process, but discussion of an effective vaccine for COVID-19 within 2020 is widespread. Caution is needed here: witness the nearly 40-year history of attempted vaccine development for AIDS, which has yet to be successful.

From Alaska to Appalachia: Rural Surgeons Tackle Unique Challenges Fighting COVID-19

Posted August 4, 2020

Nine surgeons from rural and remote communities in the U.S. share early experiences preparing for the COVID-19 pandemic. Relating experiences remarkably different from those of health care professionals in urban areas in the U.S. most affected by the first stages of the outbreak, they describe the challenges of organizing resources in facilities already struggling with poverty-stricken communities far from established health care resources and supplies. From Alaska to Appalachia and the Navajo Nation to the rural Midwest, they show the leadership and professionalism that exemplify rural surgery.

Controversy Continues Over Use of HCQ as a Prophylaxis for COVID-19

Posted August 4, 2020

The use of hydroxychloroquine (without azithromycin) for prophylaxis against the development of COVID-19 was tested in 821 U.S. and Canadian patients who were exposed to the virus—88 percent of which were high risk exposures—in a randomized, double-blind, placebo-controlled trial. The patients were recruited through standard media and social media. The investigators found no statistical benefit to the use of HCQ in preventing new illness compatible with COVID-19. In patients receiving prophylactic HCQ, 11.8 percent developed such an illness, and in the patients receiving placebo, 14.3 percent developed illness consistent with COVID-19. The difference between the two groups was -2.4 percent in favor of HCQ use , but the 95 percent confidence interval was -7.0 to 2.2, so statistical difference was unconfirmed. Incidence of side effects (largely gastrointestinal) was much higher in the HCQ group and no arrhythmias or deaths were recorded. Only two patients were hospitalized.

This study does have its shortcomings. It was performed in March, and only a small minority of the cases or illnesses attributed to COVID 19 were confirmed by polymerise chain reaction testing because of limited testing availability, so absolute confirmation of disease was not the standard for the diagnosis of COVID 19. The study will require repeating by another institution or group to confirm these results.

The use of HCQ remains controversial. The definitive/authoritative study to determine utility/effectiveness of the use of HCQ in prophylaxis or treatment of COVID 19 has yet to be published.

ACS Advisory Council for Pediatric Surgery Issues Guidelines on Postoperative Opioids

Posted July 28, 2020

The American College of Surgeons Advisory Council for Pediatric Surgery Council partnered with the American Pediatric Surgical Association and the American Academy of Pediatrics to develop guidelines for postoperative pain management in an effort to decrease opioid use in pediatric patients. The guidelines and a corresponding brochure are available.

A consensus statement from the ACS Advisory Council for Pediatric Surgery on the importance of the delivery of quality surgical care for children in underserved areas will be published. The ACS and APSA are promoting an initiative for providing fundamental surgical services and trauma care for children.

COVID-19’s influence on the pediatric surgical practice reflects the adult experience, including decreased surgical volumes and financial challenges. Pediatric surgeons and children’s hospitals have stepped up to help care for COVID-19 patients. Children with COVID-19 may have a unique manifestation of the virus—including multisystem inflammatory syndrome in children.

Now Hear This: Take Precautions When Operating on the Middle Ear and Mastoid Region

Posted July 28, 2020

A team of otolaryngologists and pathologists at Johns Hopkins Medicine, Baltimore, Md., has confirmed that COVID-19 can colonize the middle ear and mastoid region of the head. Based on this finding, the team recommends that physicians, surgeons, nurses and other health care professionals—especially otolaryngologists—practice recommended protective procedures against COVID-19 when examining, collecting samples from, treating and operating on these two connected areas. The physicians reported their findings in a research letter posted online on July 23 in JAMA Otolaryngology–Head & Neck Surgery.

“Previously, medical personnel in the otolaryngology world only had a theoretical risk on which to base a decision whether or not to follow guidelines against SARS-CoV-2,” according to C. Matthew Stewart, MD, PhD, FACS, associate professor of otolaryngology–head and neck surgery, Johns Hopkins University School of Medicine, and co-author of the letter. “Now that we have proven the virus can survive in the middle ear and mastoid, professionals in our community know the threat is real and can guard against it with appropriate procedures and protective equipment.”

Virtual Site Visits Underway for ACS-Verified Quality Improvement Programs

Posted July 28, 2020

Last week, the American College of Surgeons initiated its virtual site visit pilot program to continue work in providing accreditation/verification for ACS Quality Improvement programs while travel and in-person meetings are limited during the COVID-19 pandemic.

The Commission on Cancer conducted its first virtual site visit July 20, and the ACS Trauma Verification, Review and Consultation Program held its first site visit July 21–22. The site reviewers were selected from experienced site reviewers and members of the Verification Committee. The goals of the pilot virtual site visits are to test the feasibility and suitability of this format while ensuring high-value engagements focused on learning and sharing best practices.

In evaluating the success of the virtual site visit pilots, several points are considered, including time to prepare and complete the site visits, ease of technology and communication and sustainability of virtual site visits.

Site representatives, observers and reviewers are being surveyed after each visit to provide additional thoughts and perspectives on the process.

Information from previous virtual experiences was used to help guide the development of the pilot visits. Children’s Surgery Verification previously completed all focused site visits virtually this year. Focused site visits review specific areas that were found noncompliant during the original site visit; drawing from this experience provided useful guidance.

In addition, the Accredited Education Institutes began virtual site visits internationally in 2013 and in the U.S. in 2018, and they also shared what they have learned to help develop virtual visits for Quality Programs.

Later this week, ACS THRIVE, Trauma VRC and the National Accreditation Program for Breast Centers will hold additional visits. Looking forward, 25 virtual site visits are scheduled to take place between now and early November, with 10 scheduled in August alone.

The ACS is thankful to the sites participating in the pilot virtual site visits for their preparation and willingness to share their experience while testing this new format. Perhaps now more than ever the importance of accreditation/verification is critical in optimizing quality, safety and value for our patients. The ACS is excited about the potential of these initial pilot virtual site visits and looks forward to continuing to accredit and verify high-quality programs. We anticipate sharing our findings from the virtual site visit project.

Promising Therapeutics

Posted July 21, 2020

Hope on the Horizon? Investigators Identify Promising Vaccines for COVID-19

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, more commonly known as COVID-19) emerged in late 2019 and spread globally, prompting an international effort to accelerate development of a vaccine. According to a preliminary study in the New England Journal of Medicine and funded by the National Institute of Allergy and Infectious Diseases and others, the candidate vaccine mRNA-1273 encodes the stabilized prefusion SARS-CoV-2 spike protein.

The investigators conducted a phase 1, dose-escalation, open-label trial involving 45 healthy adults, 18−55 years old, who received two vaccinations 28 days apart, with mRNA-1273 in a dose of 25 μg, 100 μg, or 250 μg, with 15 participants in each dose group. After the first vaccination, antibody responses were higher among subjects receiving a higher dose (day 29 enzyme-linked immunosorbent assay anti–S-2P antibody geometric mean titer [GMT], 40,227 in the 25-μg group, 109,209 in the 100-μg group, and 213,526 in the 250-μg group). After the second vaccination, the titers increased (day 57 GMT, 299,751, 782,719, and 1,192,154, respectively). After the second vaccination, serum-neutralizing activity was detected by two methods in all participants evaluated, with values generally similar to those in the upper half of the distribution of a panel of control convalescent serum specimens. Solicited adverse events that occurred in more than half the participants include fatigue, chills, headache, myalgia and pain at the injection site. Systemic adverse events were more common after the second vaccination, particularly with the highest dose, and three participants (21 percent) in the 250-μg dose group reported one or more severe adverse events.

The investigators conclude that mRNA-1273 vaccine induced anti–SARS-CoV-2 immune responses in all participants and identify no trial-limiting safety concerns. These findings support further development of this vaccine.

U.K. study conducted April 23−May 21 showed that ChAdOx1 nCoV-19 had an acceptable safety profile, and homologous boosting increased antibody responses. These results, together with the induction of both humoral and cellular immune responses, support large-scale evaluation of this candidate vaccine in an ongoing phase three program.

In this study, 1,077 participants enrolled and were assigned to receive either ChAdOx1 nCoV-19 (n=543) or MenACWY (n=534), 10 of whom were enrolled in the nonrandomized ChAdOx1 nCoV-19 prime-boost group. Local and systemic reactions were more common in the ChAdOx1 nCoV-19 group and many were reduced by use of prophylactic paracetamol, including pain, feeling feverish, chills, muscle ache, headache and malaise.

New Studies Refute Claims that People with Certain Blood Types Are More Vulnerable to COVID-19 Infection

Two new studies—one at the Massachusetts General Hospital, Boston, and the other at Columbia Presbyterian Hospital, New York, NY—contradict previous findings that Type A blood increases the risk of COVID-19 infection. The new reports do find evidence that people with Type O blood may be slightly less likely to be infected; however, the effect is minimal.

ACS Remains Committed to Supporting Your Quality Improvement Efforts: Virtual Site Visits Begin

Posted July 21, 2020

Because of the travel restrictions and health and safety concerns resulting from the COVID-19 pandemic, in April the American College of Surgeons extended the accreditation/verification dates for all College-verified programs by one year. To best meet the needs of hospitals now and in the future, a virtual site visit project has launched and will continue throughout the remainder of 2020.

With continued uncertainty and variability regarding the safety of travel dependent on geographic area and the size of group gatherings, and as hospitals and health care providers throughout the country continue to cope with the effects of COVID-19, the ACS is dedicated to continuing to provide the long-term benefits of accreditation and verification while reducing travel, even as resources may be diverted.

The goal of the pilot virtual site visits is to test the feasibility and suitability of this format while ensuring high-value engagements focused on learning and sharing best practices. Information gathered through the pilot visits will be used to refine the site visit process as necessary with the intention to offer virtual site visits more widely in 2021.

Select pilot sites have been identified from each ACS accreditation and verification program as follows:

  • Commission on Cancer
  • Children’s Surgery Verification
  • Metabolic and Bariatric Surgical Accreditation and Quality Improvement Program
  • National Accreditation Program for Breast Centers
  • National Accreditation Program for Rectal Cancer
  • Trauma Verification
  • Geriatric Surgery Verification

Pilot visits for emerging verification programs, including the ACS Quality Verification, Rural, and High-Risk Gastrointestinal Surgery programs, will continue.

The ACS thanks you for all that you are doing for your patients, providers, families and communities and your commitment to achieving quality patient care. Perhaps now more than ever, the accreditation/verification process is critical to optimizing quality, safety and value for our patients. We look forward to sharing our findings from the virtual site visit project.

ACS Video Reminds Public to Play a Part in Preventing the Spread of COVID-19

Posted July 21, 2020

The American College of Surgeons has developed a new video emphasizing the precautions surgeons take every day to prevent the spread of disease and how these simple steps can help protect people from the spread of COVID-19 infection. These proactive steps include wearing a mask in public, washing your hands, and physical distancing. The animated video is being released today via social media and on the ACS website. All are welcome to download the files and use them on social media and websites as well to help share this important message.

Download and share the video

 

As COVID-19 Cases Surge in Several States, Surgeons Can Access ACS Resources for Triage of Non-Emergent Surgeries and Ethical Considerations

Posted July 14, 2020

With several states now experiencing surges in COVID-19 cases, many hospitals and surgical care professionals are again seeking guidance on triaging nonurgent care. As certain states became initial hot spots in March, the American College of Surgeons offered Recommendations for Management of Elective Surgical Procedures and Guidance for Triage of Non-Emergent Surgical Procedures. The College also addressed ethical considerations in the provision of care to COVID-19 patients. The ACS encourages surgical care providers experiencing this latest uptick in cases to review these documents to address patient care issues in these unprecedented times in accordance with the College’s principles.

ACS Supports Wearing a Face Mask to Protect Against COVID-19 Infection

Posted July 14, 2020

To help prevent the spread of COVID-19, the American College of Surgeons has issued repeated calls throughout the pandemic for individuals to practice social distancing and the use of face masks in public places. In March and April, the College recruited a number of athletes and other celebrities to develop a series of public service announcements encouraging people to stay home during the peak of the pandemic and to wear face coverings when they were in public.

Recent events have exposed significant reluctance among some people to accept a mandate to wear protective face coverings. For more than a century, surgeons have accepted the fact that airborne transmission of infection contributes to negative patient outcomes and that face masks provide some element of protection against transmission of infection from health care professionals to patients and patients to health care professionals. The COVID-19 pandemic has forced all citizens in the U.S. and other countries to recognize that airborne transmission of the virus is a significant problem as outlined in the recent report by Morawska and Milton.1 These authors  cite data supporting the fact that transmission is likely from asymptomatic infected individuals. A study by Wang2 showed that masks reduce transmission risk in households but loses effectiveness once a patient becomes symptomatic.

Other data show that measures to mitigate community transmission of COVID-19, including social distancing, mask wearing, hand washing, sheltering at home, and avoidance of crowds (especially indoors) are effective in slowing the pandemic.3 Greenhalgh4 and Javid5 summarized the evidence and concluded that although the findings are not strong, overall the evidence supports the wearing of masks to reduce transmission of the virus; they encourage government leaders and scientists to employ the “precautionary principle.” This principle is used to guide choices of interventions for problems where the supporting evidence is limited.

Because COVID-19 cases are increasing, no universally effective vaccine or treatment has been developed, and the personal and financial cost of implementing measures to mitigate transmission is reasonable compared with the cost in lives and health, the aforementioned researchers and the ACS urge adoption of these precautions, including the use of face masks. Laypeople should discipline themselves to practice mitigation measures to reduce transmission. Mask wearing is only one part of an effective approach to mitigation, but it should be included.

References

  1. Morawska L, Milton DK. It is time to address airborne transmission of COVID-19. Clin Infect Dis. 2020.
  2. Wang Y, Tian H, Zhang L, et al. Reduction of secondary transmission of SARS-CoV-2 in households by face mask use, disinfection and social distancing: A cohort study in Beijing, China. BMJ Glob Health. 2020;5(5). Available at: https://gh.bmj.com/content/bmjgh/5/5/e002794.full.pdf. Accessed July 13, 2020.
  3. Courtemanche C, Garuccio J, Le A, Pinkston J, Yelowitz A. Strong social distancing measures in the United States reduced The COVID-19 growth rate. Health Aff (Millwood). 2020;39(7):1237-1246.
  4. Greenhalgh T, Schmid MB, Czypionka T, Bassler D, Gruer L. Face masks for the public during the covid-19 crisis. BMJ. 2020;369:m1435. Available at: https://www.bmj.com/content/bmj/369/bmj.m1435.full.pdf. Accessed July 13, 2020.
  5. Javid B, Weekes MP, Matheson NJ. Covid-19: Should the public wear face masks? BMJ. 2020;369:m1442. Available at: https://www.bmj.com/content/bmj/369/bmj.m1442.full.pdf. Accessed July 13, 2020.

CMSS Issues Statement on Wearing Masks to Avert the Spread of COVID-19

Posted July 7, 2020

The Council of Medical Specialty Societies (CMSS) issued a statement, Respect Science, Wear Masks, last week. The statement calls on the federal government to implement a national mandate to wear a mask or other face covering in public. This mandate would require mask wearing when people cannot maintain physical distancing. Covering the nose and mouth are essential to prevent further spread of COVID-19, to support restarting the U.S. economy, and to reopen schools, colleges, and universities in the fall, according to the statement.

As Some States Face Surge in COVID-19, Surgeons Must Lead in Triaging Nonurgent Operations and Flattening the Curve

Posted June 30, 2020

As the number of coronavirus disease cases surge in Texas counties with large metropolitan areas—specifically, Bexar, Dallas, Harris, and Travis counties—Gov. Greg Abbott (R) issued an Executive Order June 25 limiting the types of operations that may be performed in these regions to ensure hospital bed availability for COVID-19 patients.

Under this order, the governor directs all hospitals in these counties to postpone all operations and procedures “that are not immediately, medically necessary to correct a serious medical condition or to preserve the life of a patient who without immediate performance of the surgery or procedure would be at risk for serious adverse medical consequences or death, as determined by the patient’s physician.”

Because other states experiencing similar increases in COVID-19 cases may implement like measures, the American College of Surgeons (ACS) is reoffering guidance on triage of nonurgent surgical care, including guidance for specific operations.

When COVID-19 cases began to surge in March in a number of U.S. cities, the College issued guidance noting that it is impossible to define medical urgency solely on the basis of whether a case is on a nonemergent surgery schedule. Although some cases can be postponed indefinitely, most “elective,” or nonemergent, operations are associated with progressive disease (such as cancer, vascular disease, and organ failure) that will continue to progress at variable, disease-specific rates.

As these conditions persist and often advance in the absence of surgical intervention, it is important to recognize that the decision to cancel or perform an operation must be made in the context of numerous considerations, both medical and logistical. Indeed, given the uncertainty regarding the impact of COVID-19, delaying some cases risks having them reappear as more severe emergencies at a time when they can less easily be managed.

Surgeons in former hotspots, such as New York, NY, report that they are now working around the clock to provide care to patients who had to delay surgical care.

To further assist in the surgical decision-making process to triage nonemergent operations, the ACS suggests that surgeons and other hospital leaders refer to the Elective Surgery Acuity Scale (ESAS) from St. Louis University, MO.

The College also advises states that now are seeking to “flatten the curve” to follow the lead of western Washington. Despite having the first confirmed case of coronavirus and being the first COVID-19 hotspot in the U.S., the state of Washington implemented a response plan that kept its death rate the lowest among all states that have had major outbreaks. A multidisciplinary consensus panel of 26 experts has identified six key factors that contributed to flattening the curve in the state. They report on their findings in an article in the Journal of the American College of Surgeons.

Stakeholders recognized the need for increased infrastructure to support a coordinated response, and the Western Washington Regional COVID Coordination Center was established as a Regional Medical Operations Center (RMOC). This RMOC is a vital structure and contributed to the successful response, and its example should be considered if possible.

Aerosols and Controlling COVID-19: An Infectious Disease Specialist Offers Recommendations

Posted June 30, 2020

Lisa M. Brosseau, SCD, CIH, research consultant, University of Minnesota Center for Infectious Disease Research and Policy, recently led a webinar on aerosol transmission of COVID-19. The webinar, Infectious Dose: Can It Inform COVID-19 Decisions? gave a comprehensive overview of how COVID-19 is transmitted and offered high-level recommendations for controlling infectious doses in a range of environments.

AHRQ Website Includes COVID-19 Guidance Summaries

Posted June 30, 2020

The Agency for Healthcare Research and Quality (AHRQ) has established the COVID-19 Guidance Collaborative to improve the development, dissemination, and use of “living” COVID-19 guidance. Users are participants of the AHRQ evidence-based Care Transformation Support (ACTS) initiative Stakeholder Community. Key functions are as follows:

Providing current answers for urgent clinical questions faced by health care providers and leaders; see COVID-19 Guidance Summaries (initially from Penn Medicine’s Center for Evidence-based Practice) from the Centers for Disease Control and Prevention (CDC), the World Health Organization, and other stakeholders.

Helping guidance developers/others track COVID-19-related recommendations—and updates—from CDC and other authoritative agencies (this “Workbench” functionality is in development and pending public release)

  • Fostering collaboration among those implementing the COVID-19 guidance summaries: via a Guidance Implementer Discussion Forum
  • Facilitating coordination/collaboration to optimize flow of COVID-19 "evidence-to-guidance-to action-to-data"

COVID-19 Risk Predictor/Nomogram

Posted June 30, 2020

The Cleveland Clinic has developed a risk calculator to predict the likelihood that a patient will test positive for COVID-19. The calculator measures such factors as age, ethnicity, weight, smoking, body mass index, vaccinations, and so on.

Coordinated COVID-19 Response Helped Western Washington State “Flatten the Curve”

Posted June 23, 2020

Despite having the first confirmed case of coronavirus and being the first COVID-19 hot spot in the U.S., the state of Washington implemented a response plan that kept its death rate the lowest among all states that have had major outbreaks. A multidisciplinary consensus panel of 26 experts analyzed western Washington’s response and identified six key factors that contributed to “flattening the curve” in the state. They report on their findings in an article in press on the Journal of the American College of Surgeons website.

The six pillars of the COVID-19 response identified by the consensus panel are as follows:

  • Early communication and coordination among all stakeholders including public health, academia, hospital systems, emergency medical services, and long-term care facilities (LTCFs)
  • Regional coordination and situational awareness of the health care system response
  • Rapid development and access to viral testing
  • Proactive management of LTCFs and skilled nursing facilities
  • Proactive management of vulnerable populations
  • Effective physical distancing in the community

Stakeholders recognized the need for increased infrastructure to support a coordinated response, and the Western Washington Regional COVID Coordination Center (WRC) was established as a Regional Medical Operations Center (RMOC). This RMOC is a vital structure and contributed to the successful response.

As of June 5, Washington State had 22,729 confirmed cases of COVID-19 and 1,138 ensuing deaths, a rate of about 5 percent. The overall death rate in the U.S. is 5.7 percent, according to Centers for Disease Control and Prevention data. New York State, by comparison, has had more than 380,000 confirmed cases and 30,000 deaths, a death rate of 8 percent.

“Along with the governor’s stay-at-home and physical distancing orders, preexisting relationships across the health care system were critical in facilitating this response,” said corresponding author Eileen M. Bulger, MD, FACS, chief of trauma at Harborview Medical Center in Seattle and Chair of the American College of Surgeons (ACS) Committee on Trauma. The consensus panel noted that early communication and coordination among the various hospitals systems, emergency medical services, and LTCFs was pivotal in the response.

New Study Shows Link Between Blood Type and Severity of COVID-19

Posted June 23, 2020

A study in the New England Journal of Medicine identified a 3p21.31 gene cluster as a genetic susceptibility locus in patients with COVID-19 with respiratory failure and confirmed a potential involvement of the ABO blood-group system. The study involved 1,980 patients at seven hospitals in the Italian and Spanish epicenters of the COVID-19 pandemic in Europe. After quality control and the exclusion of population outliers, 835 patients and 1,255 control participants from Italy and 775 patients and 950 control participants from Spain were included in the final analysis. In total, the authors analyzed 8,582,968 single-nucleotide polymorphisms and conducted a meta-analysis of the two case-control panels.

The authors detected cross-replicating associations with rs11385942 at locus 3p21.31 and with rs657152 at locus 9q34.2, which were significant at the genome-wide level (P < 5 × 10−8) in the meta-analysis of the two case-control panels (odds ratio, 1.77; 95 percent confidence interval [CI], 1.48 to 2.11; P = 1.15 × 10−10; and odds ratio, 1.32; 95 percent CI, 1.20 to 1.47; P = 4.9 5× 10−8, respectively). At locus 3p21.31, the association signal spanned the genes SLC6A20, LZTFL1, CCR9, FYCO1, CXCR6, and XCR1. The association signal at locus 9q34.2 coincided with the ABO blood group locus; in this cohort, a blood-group–specific analysis showed a higher risk in blood group A than in other blood groups (odds ratio, 1.45; 95 percent CI, 1.20 to 1.75; P = 1.48 × 10−4) and a protective effect in blood group O as compared with other blood groups (odds ratio, 0.65; 95 percent CI, 0.53 to 0.79; P = 1.06 × 10−5).

Public Officials Forced to Leave Their Posts Amid Waves of Protests

Posted June 23, 2020

According to an article published June 22 in The Washington Post, public health officials are leaving their jobs amid waves of protest at their homes and offices, as well as pressure from politicians who want to reopen their states or cities more quickly. Lori Tremmel Freeman, chief executive officer of the National Association of County and City Health Officials, said more than 20 health officials have been fired, have resigned, or have retired in recent weeks because of conditions related to enforcement of lockdowns and other public health tactics during the COVID-19 pandemic. Attacks on health officials have been particularly harsh in California, Colorado, Georgia, Ohio, and Pennsylvania.

ACS Fellow Performs First U.S. Double-Lung Transplant on COVID-19 Patient

Posted June 16, 2020

Ankit Bharat, MBBS, FACS, and a multidisciplinary team at Northwestern Memorial Hospital, Chicago, IL, performed the first successful double-lung transplant on a novel coronavirus (COVID-19) patient in the U.S. June 5. The woman is in her 20s and was otherwise healthy but developed a severe case of COVID-19 that resulted in hospitalization, according to Dr. Bharat, chief of thoracic surgery, department of surgery; Harold L. and Margaret N. Method Research Professor of Surgery; and associate professor of surgery and medicine, Northwestern University.

The woman was in the intensive care unit for two months on a ventilator and receiving extracorporeal membrane oxygenation (ECMO). Although she eventually cleared the coronavirus from her body, by early June, Dr. Bharat reported, the patient's lungs showed irreversible damage. She was at risk of further decline and began showing signs that her kidneys and liver were starting to fail, with no improvement in her lung function. At press time, the patient was doing well.

JACS Study Shows Reusable Elastomeric Masks Provide Better Protection than N95s

Posted June 16, 2020

A cost-effective strategy for health care systems to offset N95 mask shortages resulting from the novel coronavirus (COVID-19) pandemic is to switch to reusable elastomeric respirator masks, according to a study published in the Journal of the American College of Surgeons (JACS). These long-lasting masks, often used in industry and construction, cost at least 10 times less per month than disinfecting and reusing N95 masks, intended for single use, according to the authors of the study, published as an “article in press” on the JACS website in advance of print.

Certain Riot Control Agents Cause Respiratory and Ocular Distress, Increasing Opportunities to Spread COVID-19

Posted June 16, 2020

Recent reports in the lay media have highlighted the negative effects of riot control agents on protestors’ health, especially during the COVID-19 pandemic. Researchers have noted that tear gas and pepper spray canisters result in instantaneous irritation to the eyes, nose, mouth, skin, and respiratory tract—all problems that can spread the coronavirus and increase the severity of COVID-19. Studies of the long-term effects on individuals exposed to these agents are ongoing.

FDA Withdraws Emergency Use Authorization for Hydroxychloroquine and Chloroquine

Posted June 16, 2020

The Food and Drug Administration has withdrawn emergency use authorizations for two controversial coronavirus treatments amid concerns about their safety and effectiveness. The drugs, hydroxychloroquine and chloroquine, have failed in several recent clinical trials, and physicians say they can cause serious heart problems. The FDA had allowed their use in hospitalized COVID-19 patients and in clinical trials.

Promising Therapeutics: Benefits of Hydroxychloroquine as a Prophylactic Requires More Investigation

Posted June 9, 2020

An article in the New England Journal of Medicine (NEJM) reports the results of a controlled, randomized clinical trial involving 821 individuals who were asymptomatic for COVID-19, a large percentage of whom were at high risk of recent exposure (719 of 821 [87.6 percent]). The incidence of new illness compatible with COVID-19 did not differ significantly between participants receiving hydroxychloroquine (49 of 414 [11.8 percent]) and those receiving placebo (58 of 407 [14.3 percent]); the absolute difference was −2.4 percent. Side effects were more common with hydroxychloroquine than with a placebo (40.1 percent versus 16.8 percent), but no serious adverse reactions were reported. The investigators concluded that after high-risk or moderate-risk exposure to COVID-19, hydroxychloroquine did not prevent illness compatible with COVID-19 or confirmed infection when used as a prophylaxis within four days after exposure.

NEJM published a response to the study in which the author cites the limitations of the trial and asserts that the results are more provocative than definitive, suggesting that the potential prevention benefits of hydroxychloroquine remain to be determined.

Promising Therapeutics: NIH Trial Shows Remdesivir May Require Further Study

Posted May 26, 2020

According to a study in The New England Journal of Medicine, use of the drug remdesivir to treat COVID-19 requires further study. A total of 1,063 patients underwent randomization in the National Institutes of Health Adaptive COVID-19 Treatment Trial. The data and safety monitoring board recommended early unblinding of the results of previous findings that showed shortened time to recovery in the remdesivir group. Preliminary results from the 1,059 patients (538 assigned to remdesivir and 521 to placebo) with data available after randomization indicated that patients who received remdesivir had a median recovery time of 11 days (95 percent confidence interval [CI], 9 to 12) versus 15 days (95 percent CI, 13 to 19) for patients who received placebo (rate ratio for recovery, 1.32; 95 percent CI, 1.12 to 1.55; P<0.001). The Kaplan-Meier estimates of mortality by 14 days were 7.1 percent with remdesivir and 11.9 percent with placebo (hazard ratio for death, 0.70; 95 percent CI, 0.47 to 1.04). Serious adverse events were reported for 114 of the 541 patients in the remdesivir group who underwent randomization (21.1 percent) and 141 of the 522 patients in the placebo group who underwent randomization (27.0 percent).

Promising Therapeutics: Convalescent Plasma and Early Vaccine Data

Posted May 19, 2020

The National COVID-19 Convalescent Plasma Project has posted an article prior to peer review on the safety of use of convalescent plasma in the first 5,000 patients transfused in a large multicenter study conducted April 3−May 11. The study analyzed key safety metrics after transfusion of ABO-compatible human COVID-19 convalescent plasma in 5,000 hospitalized adults with severe or life-threatening COVID-19, with 66 percent in the intensive care unit, as part of the U.S. Food and Drug Administration Expanded Access Program for COVID-19 convalescent plasma. The incidence of all serious adverse events (SAEs) in the first four hours after transfusion was less than 1 percent, including mortality rate (0.3 percent). Among the 36 reported SAEs were 25 reported incidences of related SAEs, including mortality (n=4), transfusion-associated circulatory overload (TACO; n=7), transfusion-related acute lung injury (TRALI; n=11), and severe allergic transfusion reactions (n=3). However, only two of the 36 SAEs were judged as definitely related to the convalescent plasma transfusion. The seven-day mortality rate was 14.9 percent.

It should be noted that the patient population receiving this treatment was severely ill, so this mortality rate may not be unusual. No claims are made about shortening hospital stay, rapid amelioration of symptoms, or decreased mortality. It is simply an observational study as a Phase 1 trial for the safety of the plasma administration.

Biotech Company Announces Potential Vaccine Against COVID-19

Posted May 19, 2020

Moderna, Inc., a biotechnology company based in Cambridge, MA, May 18 announced the results of a Phase 1 study of a messenger ribonucleic acid (mRNA) therapeutic, mRNA-1273, as a potential vaccine against COVID-19. The study was led by the National Institute of Allergy and Infectious Diseases (NIAID) and showed that the vaccine was safe and effective when tested on adults ages 18 to 55 years old.

ACS Post-COVID-19 Readiness Checklist for Resuming Nonemergent Surgery Issued

Posted May 19, 2020

As states reopen, many hospitals and surgical practices are looking to assure patients who were forced to delay nonemergent operations that they will receive safe, high-quality care. To help surgeons guide patients at this time of uncertainty, the College developed the American College of Surgeons (ACS) Post-COVID-19 Readiness Checklist for Resuming Surgery, released May 14. The intent of this checklist is to help surgeons communicate the important information patients want to know. In the coming days, the ACS also will provide a tool kit of materials to help members communicate with patients regarding how they can safely return for the surgical services they need. The checklist is organized into two parts: Part I addresses the "core" facility items, and Part II addresses the "surgery specific" items.

COVID-19 Pandemic Breast Cancer Consortium Outlines Considerations for Resumption of Care

Posted May 19, 2020

The American College of Radiology, American College of Surgeons (ACS) Commission on Cancer, the ACS National Accreditation Program for Breast Centers, American Society of Breast Surgeons, American Society for Clinical Oncology, National Comprehensive Cancer Network, and Society of Surgical Oncology have collaborated to issue recommendations on safe resumption of the multidisciplinary care of breast cancer patients who experienced delays in treatment because of the COVID-19 pandemic. This document uses vignettes to illustrate the risks and benefits of resuming treatment of breast cancer as the pandemic resolves. The five clinical questions addressed are as follows:

  • How do we care for our asymptomatic but high-risk patients presenting for office visits in the post-COVID era?
  • How do we handle the backlog of patients whose surgical treatment was delayed because of the pandemic?
  • As our operating rooms reopen, how should patients who were placed on endocrine therapy prior to definitive surgery be managed?
  • As we emerge from the pandemic, how do we manage patients who have already begun neoadjuvant chemotherapy?
  • How do we manage a patient who is not a candidate for breast-conserving surgery but is ready for their operation?

The full document can be accessed here.

Guidance for Return to Practice for Otolaryngology−Head and Neck Surgery

Posted May 19, 2020

The American Academy of Otolaryngology–Head and Neck Surgery (AAO−HNS), in collaboration with the otolaryngology specialty societies, has developed recommendations for a safe return to practice, which are being presented in two parts.

  • Part One contains comprehensive general considerations that are applicable to all practice settings and specialty areas of otolaryngologists’ practice.
  • Part Two contains specific recommendations encompassing prioritization and special circumstances related to surgical procedures for all specialty areas.

These “living documents” will be updated regularly as new information becomes available.

These documents were prepared by the AAO-HNS Future of Otolaryngology Task Force with input from the Infectious Disease and Patient Safety and Quality Improvement Committees. The AAO-HNS approached the specialty societies within otolaryngology to set up a collaborative process to produce guidance for otolaryngologists that would be consistent, practical, and implementable at the appropriate time, based on local conditions and regulatory guidance. The American Academy of Otolaryngic Allergy (AAOA), American Broncho-Esophagological Association (ABEA), American Laryngological Association (ALA), American Neurotology Society (ANS), American Otological Society (AOS), American Rhinologic Society (ARS), American Head and Neck Society (AHNS), American Society of Pediatric Otolaryngology (ASPO), and the International Surgical Sleep Society (ISSS) worked with the corresponding AAO-HNS Committee to submit recommendations from their respective areas of expertise.

HHS Reports on COVID-19-Related Activities

Posted May 19, 2020

The U.S. Department of Health and Human Services (HHS) continuously provides updates from its various agencies on activities and policies related to COVID-19. These agencies include the Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services (CMS), the National Institutes of Health (NIH), and the Federal Emergency Management Administration (FEMA). Highlights from this past week that may be of interest to surgeons and other surgical care professionals include the following:

  • The FDA issued an Emergency Use Authorization (EUA) for infusion pumps and infusion pump accessories that, among other things, meet certain safety, performance, and labeling criteria, in response to concerns relating to the insufficient supply and availability of the devices for use by health care providers in the continuous infusion of medications, total parenteral nutrition, and/or other fluids into patients during the COVID-19 pandemic.
  • The CDC updated its Operational Considerations for Containing COVID-19 in non-U.S. Healthcare Settings. These documents were created for health care facilities with limited resources (such as staff shortages and supply shortages), particularly in low- and middle-income countries.
  • CMS updated its FAQ document on Medicare Fee-for-Service Billing to respond to questions about accountable care organizations and the Shared Savings program.
  • NIH Director Francis S. Collins, MD, PhD, posted a blog on how COVID-19 Brings Health Disparities Research to the Forefront.
  • The CDC released its weekly COVIDView update focused on COVID-19 testing results and mortality rates.
  • The CDC released a health advisory for Multisystem Inflammatory Syndrome in Children (MIS-C) Associated with Coronavirus Disease 2019 (COVID-19). The web page includes background information on several cases of a recently reported multisystem inflammatory syndrome in children (MIS-C) associated with COVID-19, and a case definition for this syndrome. The CDC recommends health care providers report any patient who meets the case definition to local, state, and territorial health departments to enhance knowledge of risk factors, pathogenesis, clinical course, and treatment of this syndrome.
  • NIH Director Dr. Collins and Johnson & Johnson executives published an article in JAMA May 18 on Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV). In it, they note that to respond to the generational public health crisis caused by the global COVID-19 pandemic, a swift, coordinated effort across many sectors of society is necessary.
  • The CDC updated its Interim Clinical Guidance for Management of Patients with Confirmed Coronavirus Disease (COVID-19) to include new information for pediatric management as well as information about COVID-19-associated hypercoagulability and updates and resources to include new NIH treatment guidelines.
  • The FDA issued an EUA for the G Medical VSMS ECG Patch intended to be used by health care professionals in the hospital setting for remote monitoring of the QT interval of an electrocardiogram in general care patients who are 18 years of age or older and are undergoing treatment for COVID-19 with drugs that can prolong QT intervals (measurements used to evaluate some of the electrical properties of the heart) and may cause life-threatening arrhythmias (such as hydroxychloroquine or chloroquine, especially when used in combination with azithromycin).
  • FEMA released State-by-State PPE Data, which outline how many respirators, surgical masks, face shields, surgical gowns, gloves, ventilators, and federal medical station beds that FEMA, HHS, and the private sector have delivered or shipped to states.
  • HHS Secretary Alex Azar II issued a statement on National Emergency Medical Services personnel week, celebrating emergency medical technicians and paramedics.

ACS President Valerie W. Rusch, MD, FACS, Provides Insights on Ramping Up Elective Operations

Posted May 12, 2020

Valerie W. Rusch, MD, FACS, President of the American College of Surgeons (ACS), in a video interview with Medscape, described the conditions under which it is safe to provide elective operations to patients during the COVID-19 pandemic. Dr. Rusch outlined the College’s guidelines for reopening elective services as well as the precautions in place at Memorial Sloan Kettering, New York, NY, where she is a thoracic surgeon.

Promising Therapeutics Update

Posted May 12, 2020

As the race to develop effective and safe vaccines to prevent SARS-CoV-2 infection heats up, there is increasing attention to how best to quickly prove efficacy in prevention of COVID-19. One controversial proposal is to deliberately infect volunteers to receive the virus after vaccination and then assess response, safety, and efficacy.

An article published recently in The Lancet discusses triple anti-viral drug therapy for COVID-19 improving outcomes compared with standard therapy. The use of a combination drug (lopinavir/ritonavir), ribavirin, and interferon beta-1b showed more rapid clearance of the virus, shortened hospital stay, and symptom improvement. Importantly, this trial was performed in COVID-19 patients within seven days of symptom onset with mild to moderate disease, not severe disease.

Everyone Is Talking About Testing, But They’re Thinking About It All Wrong, According to This Perspective in Health Affairs

Certain Filtering Facepiece Respirators from China May Not Provide Adequate Respiratory Protection - A Letter to Health Care Providers from the FDA

To Reopen or Not to Reopen? American College of Physicians Offers Guidance

Posted May 12, 2020

The American College of Physicians (ACP) has developed public policy guidance for federal, state, and local authorities, and other stakeholders to address the increasing calls for the U.S. and state and local governments seeking to “reopen” certain economic, social, and medical care activities. The ACP maintains that some of these policies are in conflict with what public health experts believe to be the best, safest, and most effective approaches to slow the spread of the COVID-19 virus and lower mortality rates.

Virologist Recovering from COVID-19 Offers Perspective on Overcoming the Pandemic as Published in Science

Posted May 12, 2020

A virologist who has spent his career fighting infectious diseases, including human immunodeficiency virus and Ebola, describes his experience as a COVID-19 patient. In his article, published in a recent edition of Science, Peter Piot, director of the London School of Hygiene & Tropical Medicine, U.K., states, “Without a coronavirus vaccine, we will never be able to live normally again. The only real exit strategy from this crisis is a vaccine that can be rolled out worldwide. That means producing billions of doses of it, which, in itself, is a huge challenge in terms of manufacturing logistics.” He urges reform of the World Health Organization to “make it less bureaucratic and less dependent on advisory committees in which individual countries primarily defend their own interests.”

Latest Updates from Department of Health and Human Services

Posted May 12, 2020

The U.S. Department of Health and Human Services (HHS) has taken further action on the following COVID-19-related issues:

Remdesivir: HHS announced the allocation plan for the drug remdesivir. The allocation to all 50 states, the District of Columbia, and U.S. territories is from a donation by Gilead Sciences, Inc. The donated doses of treatment, which received an Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA), will be used to treat severely ill hospitalized COVID-19 patients.

Testing plan: HHS officials and the Administration have announced a plan to help states test 2 percent of their population in May. The federal government is providing states with testing resources to meet this goal including $11 billion from the CARES Act and 12.9 million swabs, which will be disseminated to states, territories, and tribes.

First antigen test authorized: The FDA has issued the first EUA for a COVID-19 antigen test.

Expanding laboratory testing capacity: The Centers for Medicare & Medicaid Services (CMS) issued guidance on how Medicare Pharmacies and Other Suppliers May Temporarily Enroll as Laboratories to Help Address COVID-19 Testing.

Coordinating across sectors to accelerate vaccine development: The National Institutes of Health (NIH) released a perspective piece stating that a coordinated strategy to accelerate multiple COVID-19 vaccine candidates is key.

Respirator decontamination system: The FDA issued an EUA for the Duke Decontamination System for use in decontaminating compatible N95 or N95-equivalent respirators for reuse by health care personnel when insufficient supplies of these respirators are available.

Addressing drug shortages: The FDA approved an Abbreviated New Drug Application for lidocaine hydrochloride injection USP, 1 percent, which is indicated for production of local or regional anesthesia and a drug listed in the FDA Drug Shortage Database.

COVID-19 and mental and substance use disorders: The Substance Abuse and Mental Health Services Administration updated Considerations for the Care and Treatment of Mental and Substance Use Disorders in the COVID-19 Epidemic.

CDC activities and initiatives: The Centers for Disease Control and Prevention (CDC) released a document on Activities and Initiatives Supporting the COVID-19 Response and the President’s Plan for Opening America Up Again.

Medicare hospital payment rules: The Centers for Medicare & Medicaid Services (CMS) released the proposed rule for inpatient prospective payment systems (IPPS) and long-term acute care hospitals (LTCH). The deadline for submitting comments is July 10.

Medicare accelerated and advance payments: CMS updated its information for states and by provider type on the program payouts as of May 2. The CMS Accelerated and Advance Payment (AAP) Program is designed to increase cash flow to Medicare providers and suppliers impacted by the COVID-19 pandemic.

Additional flexibilities for hospitals and facilities: CMS continues to release additional blanket waivers during the duration of the public health emergency.

Additional flexibilities for states: CMS has approved more than 175 requests for state relief in response to the COVID-19 pandemic, including recent approvals for Alabama, Alaska, California, District of Columbia, Georgia, Maine, Massachusetts, Minnesota, Mississippi, Montana, Nebraska, New Mexico, Oregon, South Carolina, Rhode Island, Tennessee, Virginia, and Wisconsin.

Telehealth and Medicare coverage: CMS updated a video that answers common questions about the expanded Medicare telehealth services benefit during the COVID-19 public health emergency.

AI Might Help You Maximize Elective Surgery

Posted May 12, 2020

To help surgeons work through “elective” backlogs more quickly, safely, and efficiently, Qventus, the leader in AI-based patient flow automation systems, has released a predictive model to enable hospital administrators to maximize operating room time available to surgeons on a daily basis and more accurately forecast how long windows of opportunity will remain open.

Remind Patients They Save Multiple Lives When They Wear Masks in Public

Posted May 12, 2020

The available evidence suggests that near-universal in adoption of non-medical masks when out in public, in combination with complementary public health measures, could successfully reduce effective-R to below 1.0, thereby stopping community spread. Economic analysis suggests that the impact of mask wearing could save the U.S. thousands lives and dollars per person, per mask.

Critical Guidelines and Selected Readings

Posted May 12, 2020

Which COVID-19 Data Can You Trust?

Guidance for Return to Practice for Otolaryngology–Head and Neck Surgery

Posted May 8, 2020

The American Academy of Otolaryngology−Head and Neck Surgery, in collaboration with the otolaryngology specialty societies, developed recommendations for a safe return to practice, presented in two parts. These will be “living documents” that will be updated on a regular basis as new information becomes available.

Ophthalmic Organizations Offer Checklist for Reopening Surgical Services

Posted May 8, 2020

The American Academy of Ophthalmology, the American Society of Cataract and Refractive Surgery, and the Outpatient Ophthalmic Surgery Society have developed a checklist for reopening ophthalmic surgical services.

The checklist, issued May 6, details how to approach and manage some of the key decisions in reopening more normal practice in the COVID-19 era and was developed in collaboration with the Ambulatory Surgery Center Association.

COVID-19 Continues to Affect Small Physician Practices

Posted May 8, 2020

An article published this week in the New York Times points to the financial challenges that small physician practices across the U.S. continue to face in the COVID-19 era and to the broader impact of this crisis on the nation’s economic downturn.

As patients postpone medical appointments, elective operations, and diagnostic screenings, health spending dropped an annualized rate of 18 percent in the first three months of the year, according to recent federal data.

Congress has provided tens of billions of dollars to the hospitals reporting large losses and passed legislation to send even more, but has been less responsive to small physician practices, particularly in medicine’s least profitable fields like primary care and pediatrics. Furthermore, none of the money that lawmakers have allocated has been specifically targeted to physicians. As reported previously, funds have been set aside for small businesses, including many physicians’ practices, and the U.S. Department of Health and Human Services has taken some steps to help small practices, including advancing Medicare payments and reimbursing physicians for telehealth services.

Latest Updates from Department of Health and Human Services

Posted May 8, 2020

The U.S. Department of Health and Human Services (HHS) has taken further action this week on COVID-19-related issues.

Policy to expand testing capacity: The Food and Drug Administration (FDA) released an updated policy for COVID-19 tests with guidance for clinical laboratories, commercial manufacturers, and agency staff.

Expanding access to convalescent plasma: The Biomedical Advanced Research and Development Authority (BARDA) has entered into a collaboration with Mayo Clinic to support an expanded access program to provide access to convalescent plasma for patients hospitalized with COVID-19.

Reporting cases of COVID-19: The Centers for Disease Control and Prevention (CDC) updated its information for health departments on reporting cases of COVID-19.

First authorized serology test: The FDA authorized the first serology, or antibody, test where the results of a new independent validation effort by the U.S. government provided the scientific evidence used to support the authorization.

CDC grows the viral culture: The CDC has supported global efforts to study and learn about SARS-CoV-2 in the laboratory by growing the virus in cell culture and ensuring its wide availability. Researchers in the scientific and medical community may use the virus obtained from this work in their studies.

Optimizing the supply of personal protective equipment (PPE): The CDC updated its web page on strategies to optimize the supply of PPE.

Information on collection of postmortem specimens: The CDC updated its guidance on collection and submission of postmortem specimens from deceased persons with known or suspected COVID-19.

CDC Reports on Number of COVID-19 Cases and Deaths in U.S.

Posted May 8, 2020

According to the National Center for Immunization and Respiratory Diseases (NCIRD), as of May 6, more than 1.19 million confirmed or probable cases of COVID-19 have been identified in the U.S. Global confirmed cases of COVID-19 totaled more than 3.5 million as of May 5. In addition, the Centers for Disease Control and Prevention (CDC) has reported that 70,652 people in the U.S. have died of COVID-19 to date.

Promising Therapeutics

Posted May 8, 2020

COVID-19 and Herd Immunity

An article in Cell discusses how the emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and its associated disease, COVID-19, has demonstrated the devastating impact of a novel, infectious pathogen on a susceptible population.

Hydroxychloroquine Fails to Improve Outcomes in a Large New York City Study

The New England Journal of Medicine published a large observational study (1,376 patients) treated in New York, NY, for COVID 19 between March 7 to April 8, with follow up through April 25. This nonrandomized but well-controlled study examined the outcomes of patients treated with hydroxychloroquine (59 percent) versus patients who did not receive hydroxychloroquine (HCQ) and observed no difference in death or intubation in the two groups when illness severity was adjusted. For this study use of hydroxychloroquine was decided upon by individual attending physician judgment, and some patients treated with hydroxychloroquine also received azithromycin. A small number of patients received remdesivir in a randomized controlled trial and another small number received sarilumab.

This study does not recommend the use of HCQ outside of a randomized clinical trial.

Former CDC Chief Testifies on Preventing COVID-19 and Prevention of Future Epidemics

Posted May 8, 2020

Thomas R. Frieden, MD, former Director, Centers for Disease Control and Prevention (CDC), and now President and Chief Executive Officer, Resolve to Save Lives, testified this week before the U.S. House of Representatives Labor, Health and Human Services, and Education Appropriations Subcommittee. Dr. Frieden’s testimony provided a perspective on where the nation is and what needs to be done to protect Americans from COVID-19 and future pandemics. He proposed a new approach to bring stability and security to our efforts to keep the U.S. safer from epidemics, underscoring that the war against COVID-19 will be long and difficult, and, until we have a vaccine, we must have a comprehensive strategy and use data to drive our policies and programs in order to save lives and restore the economy. Read his testimony here.

Do Llamas Play a Role in Fighting COVID-19? New Study May Provide Immunization Insights

Posted May 8, 2020

Coronaviruses, including COVID-19, make use of a large envelope protein called spike (S) to engage host cell receptors and catalyze membrane fusion. Because of the vital role that S proteins play, they represent a vulnerable target for the development of therapeutics. An article in Cell describes the isolation of single-domain antibodies (VHHs) from a llama immunized with prefusion-stabilized coronavirus spikes. The data provide a molecular basis for the neutralization of pathogenic beta coronaviruses using VHHs and suggest that these molecules may serve as useful therapeutics during the COVID-19 outbreak.

Interpreting COVID-19 Diagnostic Tests

Posted May 8, 2020

Scientific knowledge of diagnostic tests for COVID-19 continues to evolve. A “Viewpoint” in the Journal of the American Medical Association describes how to interpret two types of diagnostic tests commonly in use for COVID-19 infections—reverse transcriptase-polymerase chain reaction (RT-PCR) and IgM and IgG enzyme-linked immunosorbent assay (ELISA)—and how the results may vary over time.

The Latest in Promising Therapeutics: Remdesivir, Convalescent Plasma, and Antibody Testing

Posted May 5, 2020

The Food and Drug Administration (FDA) has issued emergency use authorizations for remdesivir to treat COVID-19 and a new antibody test from Roche, as well as new guidance for investigational new drug applications for convalescent plasma in severe COVID-19.

The FDA issued an emergency use authorization (EUA) for the use of remdesivir in treatment of COVID-19, effective May 1, which enables remdesivir to be used outside a clinical trial more easily. Last week, the National Institute of Allergy and Infectious Diseases (NIAID) reported findings from a preliminary analysis of remdesivir, which indicated that hospitalized patients with advanced COVID-19 and lung involvement who received remdesivir recovered faster than similar patients who received a placebo.

The FDA also issued new guidance for investigational new drug (IND) applications for the use of convalescent plasma in patients with severe COVID-19 disease. This guidance includes pathways for clinical trials and single patient emergency INDs. For single patient emergency INDs, physicians must determine that the probable risks of administering this treatment to a patient is not greater than the probable risk from the disease. These applications may be made 24 hours/day and seven days/week and can be accessed here.

In addition, the FDA issued an EUA May 3 for the use of a COVID-19 antibody test from Roche. This test confirms exposure to the SARS-CoV-2 virus with detection of formation of antibodies to the virus. When done 14 days after a positive confirmation of a SARS-CoV-2 test, this antibody test has a specificity of 99.8 percent and a sensitivity of 100 percent, meaning false negatives and false positives are rare. The data at this time are too limited to determine if this test is effective in measuring immunity to reinfection or how long the antibodies persist after exposure.

New Guidelines for Thoracic Procedures from the American Association for the Surgery of Trauma

Posted May 5, 2020

New American Association for the Surgery of Trauma guidelines for thoracic procedures, including chest tube placement and removal, recommend the development of a local protocol that includes a risk-benefit assessment before procedures are performed, as well as careful protection of health care professionals before, during, and after the procedures.

Assembling a thoracic procedures team and portable equipment bags for tube thoracostomy is recommended. A clear thoracic procedure algorithm and step-by-step descriptions of procedures are provided. One recommendation includes adding bleach to the water seal chamber in the chest tube drainage apparatus. Whereas most commercially available thoracotomy systems contain a 45–60mL water seal volume, 1 mL of bleach may be added to 50mL of water. The paper encourages clinicians to be cognizant of local protocols to ensure optimal integration with national recommendations for these procedures.

Stepping Outside Your Typical Scope of Work? Resources from the University of Wisconsin May Help

Posted May 5, 2020

The University of Wisconsin-Madison (UW) has developed guidance for surgeons and other health care professionals who do not routinely provide trauma/burn or intensivist care, as many providers have been asked to step out of their typical scope of work because of COVID-19. UW is making the resources widely available via the ACS.

These resources include:

  • Trauma and Burn Primer: Reviews evaluation and management of common trauma and burn diagnoses for the general surgeon who does not normally care for trauma/burn patients
  • UW Critical Care Team Visit Work Flow: A checklist to guide critical care team rounds
  • “Primer” on Caring for Critical Care Patients: Covers common topics and diagnoses within critical care, from ventilator modes to sepsis and beyond
    • UW COVID-19 Critical Care Primer: Provides a high-yield guide to the diagnosis, treatment, and outcomes of critically ill COVID-19 patients
    • UW General Critical Care Primer: Offers a systems-based rounding format with a quick review of core topics and management decisions to be addressed during rounds
    • “Primers” for Specific Patient Populations: Designed to be used as a supplement to the UW General Critical Care Primer
      • UW Medical Critical Care Primer: Highlights specific diagnoses commonly seen in the medical intensive care unit (ICU) (“trauma and life support center”)
      • UW Surgical Critical Care Primer: Highlights specific diagnoses commonly seen in the surgical ICU, including some protocol-based outlines of care for common injuries and surgical procedures
  • UW Must Call ICU List should be reviewed by lower “tiered” providers as a reminder for when to contact the supervising ICU faculty
  • Thinking Simple about Ventilator Management: Four-part voice-annotated PowerPoint presentation reviewing the basics of ventilators

For more information, contact Angela “Angie” Ingraham, MD, MS, FACS, Assistant Professor of Surgery, University of Wisconsin-Trauma and Acute Care Surgery at 608-262-6246 or ingraham@surgery.wisc.edu. Dr. Ingraham and an interdisciplinary team at UW developed these materials.

U.S. Department of Health and Human Services Provides Information to Guide States on Reopening

Posted May 5, 2020

As governors move forward on decisions to reopen some parts of their states, the Administration is issuing guidance for the range of situations that are part of reopening. An excerpt of the latest guidance can be found here.

Testing updates

  • Contact tracing training guidance: The Centers for Disease Control and Prevention (CDC) released a training module on contact tracing. This web page contains a sample training plan that may be helpful for state and local public health jurisdictions to consider when designing their own training programs for COVID-19 contact tracers. Suggested training modalities/formats are provided, as well as information about existing training initiatives and resources. This document may be updated as new resources become available.
  • Information on evaluation and testing patients: The CDC updated its guidance on evaluating and testing persons for COVID-19. The updates include recommendations for testing, specimen collection, reporting patients and reporting positive test results, and specification of testing priorities.
  • CDC resources for testing: The CDC released a new fact sheet on federal resources for COVID-19 contact tracing staff, which describes several ways health departments can access additional staffing for COVID-19 contact tracing, including through State Service Commissions and AmeriCorps Programs, the CDC, and the Federal Emergency Management Agency (FEMA).

Treatment updates

  • Symptom-based strategy for discontinuing isolation: The CDC released updated recommendations for discontinuing isolation. In the context of community transmission where continued testing is impractical, available evidence at this time indicates that an interim strategy based on time-since-illness-onset and time-since-recovery can be implemented to establish the end of isolation.
  • Updated information on discontinuing isolation: The CDC also updated its discontinuation of isolation for persons with COVID-19 who are receiving care outside of health care facilities. Updates include extending the home isolation period based on evidence suggesting a longer duration of viral shedding and will be revised as additional evidence becomes available. The clinical care guidance for health professionals and information on what to do if you are sick also were updated to reflect this change.

Information for specific populations

  • Tips for health care systems to operate effectively: The CDC released 10 ways health care systems can operate effectively during the COVID-19 pandemic. This document provides practical approaches that can be used to protect health care personnel (HCP), patients, and communities. The tips include information on work safety and support, patient service delivery, data streams for situational awareness, facility practices, and communications.
  • Information for pediatric health care providers: The CDC updated its resources for pediatric health care providers on what to do when managing pediatric patients with suspected or confirmed COVID-19. The web page has information on maintaining childhood immunizations during the pandemic, the burden of COVID-19 among children, the clinical presentation of COVID-19 in children, treatment and prevention for children, and additional resources.
  • Information for environmental health practitioners: The CDC posted information for specific environmental health practitioners, including congregate facilities and shelters such as general population disaster shelters, correctional and detention facilities, retirement communities, child care centers that remain open, cooling centers, and more. This web page provides information for environmental health practitioners from the CDC and other trusted sources.

Promising Therapeutics

National Institutes of Health NIAID Reports Findings from New Study of Anti-Viral Treatment Remdesivir in Advanced COVID-19 Patients

Posted May 1, 2020

The National Institute of Allergy and Infectious Diseases (NIAID) reported findings from a preliminary analysis of a randomized, placebo-controlled trial investigating the anti-viral treatment remdesivir in 1,063 advanced COVID-19 patients. The results found that hospitalized patients with advanced COVID-19 and lung involvement who received remdesivir recovered faster than similar patients who received placebo.

Specifically, preliminary results indicate that patients who received remdesivir had a 31 percent faster time to recovery than those who received placebo (p < 0.001). The median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received placebo. The mortality rate for the group receiving remdesivir was 8.0 percent versus 11.6 percent for those receiving the placebo, not quite statistically significant (p = 0.059).

American Society for Gastrointestinal Endoscopy Issues Guidance on Resuming Elective Procedures

Posted May 1, 2020

The American Society for Gastrointestinal Endoscopy (ASGE) has issued guidance for resuming elective gastrointestinal (GI) endoscopy and practice operations after the COVID-19 pandemic. The document contains recommendations surgeons and other providers of these services can use to mitigate infection risks during the gradual reopening of endoscopy centers and GI clinics.

The ASGE anticipates that physician and facility readiness to resume clinical operations will vary based upon the status of the pandemic in a given geographic location and will evolve gradually based on local conditions and guidance from public authorities.

Specific topics covered in the guidance document include the following:

  • Safety of patients and staff
  • Distancing and personal protective equipment considerations for the office
  • Scheduling of procedures
  • COVID-19 testing
  • Day of procedure activities

To view the full list of recommendations, click here.

Royal College of Surgeons Produces Guidance on Resuming Elective Operations

Posted May 1, 2020

To support the safe and efficient resumption of elective surgery, the Royal College of Surgeons has produced guidance for the Recovery of Surgical Services during and after COVID-19, which provides a series of principles, recommendations, and key considerations that can be used in conjunction with national, specialty, and local recovery plans.

These recommendations center on nine key themes to allow services to provide safe and efficient patient care, but also to ensure that when surgery resumes, it does not have to stop again:

  1. Key considerations before resuming elective services
  2. Developing cohesive leadership and process of frequent communication
  3. Assessing surgical workload and patient population
  4. Ensuring adequate hospital capacity and facilities
  5. Enhancing workforce capacity
  6. Reconfiguring services
  7. Supporting the surgical workforce
  8. Patient communication
  9. Supporting training

Elective Operations May Resume in Some States, but May Be Too Late for Some Rural Providers

Posted May 1, 2020

Governors in several states have begun issuing orders that surgeons and hospitals can resume elective operations, but for some rural providers it may be too late. In an interview with a National Public Radio affiliate, Michael Sarap, MD, FACS, Chair of the Department of Surgery at Southeast Ohio Regional Medical Center, Cambridge, and Chair of the American College of Surgeons Advisory Council for Rural Surgery, said the COVID-19 pandemic could be a “death knell” for rural hospitals in southeast Ohio and across the nation.

“It’s just been an absolute crisis in the last three to five years,” Dr. Sarap said. “Every single week we hear about another rural or small community hospital that has closed, has gone bankrupt, or their larger institution has closed, and this is just going to make the situation much, much worse.”

Before the pandemic, a number of hospitals in rural areas already had closed. Data from the University of North Carolina at Chapel Hill Rural Health Research Program shows 170 rural hospitals have closed in the U.S. since 2005. Many of these are in the Midwest and in the South, with higher rates of closure in states that did not expand Medicaid.

Ten rural hospitals have shut their doors already in 2020, including two in West Virginia. Dr. Sarap said factors that force rural hospitals to close include declining rural populations, poorer patients, the inability to recruit and retain physicians, increasing debt, and the rising cost of doing business.

Gynecological Societies Release Joint Statement on Re-Introduction of Hospital and Office-Based Procedures

Posted May 1, 2020

Urogynecologic and gynecological societies have released a joint statement describing a developed several-tiered ranking system for prioritization of operations during the COVID-19 pandemic. Based on a ranking system created by the ACS, the list guides urogynecologic and benign gynecologic surgeons and is meant to help surgeons and their health care systems decide who should go to the operating room as the pandemic unfolds.

While the tiered system also applies to outpatient procedures, the tiered system must account for the patient’s gynecologic condition, as well as their medical comorbidities, and be able to adapt to changing conditions. Read the joint statement here.

Commentary on Updated American Heart Association Resuscitation Guidelines

Posted May 1, 2020

To provide guidance on necessary adaptations to life support practices for patients with confirmed or suspected COVID-19 infections, the American Heart Association, in association with the several other medical organizations, recently published Interim Guidance for Life Support for COVID-19.

The document includes tips on provider safety during cardiopulmonary resuscitation (CPR) and intubation after cardiac arrest, strategies to minimize aerosolization, and guidance for resuscitation in children and neonates. Because the recommendations provided in the article focus on the techniques that providers can use to obtain the best clinical results possible in challenging situations they do not provide perspective on some aspects of care that are potentially important for caregivers, patients, and family members. For example the time required to properly don personal protective equipment is important to consider because seconds can be the difference between life and death for a coding patient. Furthermore, all life support decisions should begin with an informed discussion with patients and families as early as possible.

A multi-society collaboration has provided new interim guidance on basic and advanced life support during the COVID-19 pandemic. The recommendations update the standard American Heart Association (AHA) guidelines for cardiopulmonary resuscitation (CPR) in light of the disruptive conditions of the pandemic. Strengths of the document include tips on provider safety during CPR and intubation after cardiopulmonary arrest, as well as the inclusion of pediatric, maternal, and neonatal populations. Guidance also is offered on oxygenation and ventilation strategies that minimize aerosolization risk, such as using viral filters on ventilation equipment and considering video laryngoscopy to potentially reduce intubator exposure to aerosolized particles.

Although the update is necessary and timely, there are few substantial changes from current practice that safety-minded providers will not have already considered if they have been keeping current with the COVID-19 literature, which is rife with suggestions on personal protection for providers. In addition to technical considerations during CPR, one would have liked to see more detailed recommendations on the appropriateness of doing CPR on patients with COVID-19. This topic is mentioned, but ultimately the advice provided is for health care systems and emergency medical system (EMS) agencies to develop their own policies on the topic. The guidance would have been strengthened by input from ethics or palliative care societies to address these high-risk circumstances and from stressing the critical need for goals of care and code status discussions upon admission to the hospital.

Considering the high mortality rate of inhospital cardiac arrest in general, arrest in a patient with COVID-19-related respiratory failure immediately poses the dilemma of risk to providers versus benefit to patients. A more detailed discussion of this topic would have been informative. With CPR, seconds count, but donning appropriate personal protective equipment (PPE) takes considerable time. The potentially deleterious effects of taking time to don appropriate PPE, especially powered air purifying respirators (since CPR is an aerosol-generating procedure), on CPR outcomes are not discussed. The section reviewing CPR with patients in the prone position also misses an opportunity to present the pros and cons of doing so. Considering that patients being “proned” are by definition hypoxemic and the effectiveness of CPR in prone position is questionable, the combination of these may portend poor neurologic outcomes.

Ultimately, these recommendations will be particularly useful in the future when the lessons of the pandemic are not as fresh. This document will be a good resource to remind us of the many “tricks of the trade” that have been developed to mitigate risk while providing complex care for those with transmissible viral infections.

As health care workers, we are the highest-risk profession for contracting COVID-19. To provide the best care for these patients, as well as to protect ourselves, professional associations such as the American Association of Critical Care Nurses and National EMS Physicians also have provided useful guidelines on resuscitation, available at aacn.org.

The AHA guidelines describe the Out-of-Hospital Cardiac Arrest (OHCA) as well as the procedures required for In-Hospital Cardiac Arrest (IHCA). The document outlines, in great detail, the recommendations to minimize aerosolization of the virus and has an appendix in neonatal and maternal resuscitation. All the techniques delineated are particularly useful when dealing with a patient in extremis.

The first step on this issue should be having an informed discussion with the family before the issue of cardiovascular arrest presents itself. Patients in multi-organ system failure, with or without COVID-19, carry a significant risk of mortality, as well as morbidity if resuscitated successfully—they may require dependence on a ventilator or on dialysis. An honest, informed conversation about goals of care should take place before all efforts, not only to minimize the health care workers exposed to the virus, but to ensure that the family is prepared for the outcome and understands the ramifications of cardiovascular resuscitation on a pulseless patient.

North Carolina Urology Group Develops Guide to Adopting Telehealth

Posted May 1, 2020

COVID-19 stay-at-home orders caught many medical practices and health care systems off guard, leaving them ill-equipped to rapidly adopt an efficient telehealth platform so they could keep providing time-sensitive care. To help physician practices and medical centers rapidly introduce telemedicine as an alternative option, a Wake Forest Baptist urology group, Winston-Salem, NC, developed a guide that enabled them to convert all in-person visits to telehealth in three days. They report their experience in an article in press on the Journal of the American College of Surgeons website ahead of print.

The article outlines the eight essential steps involved in adopting telemedicine: an existing electronic health record system; a one-hour training session for providers and staff; patient education on accessing the portal; availability of hardware, such as smartphones and video-capable computers; integration of new billing and coding functions, information technology support; an audiovisual platform; and patient and caregiver buy-in.

Treatment for Disordered Coagulation in COVID-19 Patients

Posted April 28, 2020

An expert panel assembled under the sponsorship of several professional medical associations prepared a detailed, comprehensive summary of the pathophysiology of thrombotic events that accompany infection with COVID-19, as well as evidence-based recommendations for diagnosis and management of these conditions.

The authors note that evidence of disordered coagulation is present in patients with moderate or severe COVID-19 infection and that clinically important venous thromboembolic events (VTE) frequently are observed in hospitalized COVID-19 patients. Surgeons who have cared for COVID-19 patients have confirmed that deep venous thrombotic events, as well as thrombosis of intravascular catheters and dialysis access catheters, are observed with increased frequency in these patients.

Abnormalities in D-dimer levels, fibrinogen degradation products, and prothrombin time will confirm the presence of microvascular thrombotic events. Of interest is the fact that the authors did not mention monitoring patients with thrombo-elastography. Testing with this modality could identify the specific coagulation mechanism(s) affected by the disease. Severely ill patients with pulmonary insufficiency, shock, and organ failure may fulfill criteria for diffuse intravascular coagulation syndrome. The expert panel recommended assessment of risk for VTE using scoring systems such as the Caprini score and implementation of VTE prophylaxis with low molecular weight heparin or direct acting anticoagulant agents. The authors noted that the difficulty in obtaining venous imaging because of risks of spreading COVID-19 infection might justify therapeutic anticoagulation in patients at high risk rather than waiting for symptoms to occur. The article supplies detailed recommendations and useful illustrations of algorithms for management of venous thromboembolism, acute coronary syndrome, and other relevant conditions.

Promising Therapeutics

Posted April 28, 2020

FDA and NIH Advise Using HCQ and Other Drugs Only as Part of Clinical Trials

The Food and Drug Administration (FDA) and the National Institutes of Health (NIH) COVID-19 Guidelines Panel released important guidance on the use of chloroquine, hydroxychloroquine (HCQ), and azithromycin to prevent or treat the novel coronavirus.

The FDA issued a Drug Safety Communication April 24 regarding the use of chloroquine and HCQ, especially with azithromycin. The FDA reviewed case reports in its Adverse Event Reporting System, the published medical literature, and the American Association of Poison Control Centers National Poison Data System concerning serious heart-related adverse events and death in patients with COVID-19 receiving HCQ and chloroquine, either alone or combined with azithromycin. These adverse events were reported from the hospital and outpatient settings for treating or preventing COVID-19, and included cardiac rhythm abnormalities, including QTc interval prolongation, ventricular tachycardia, and ventricular fibrillation, and in some cases death.

The FDA recommends that health care professionals conduct initial evaluation and monitoring when using HCQ or chloroquine in clinical trials for the treatment or prevention of COVID-19. If a health care professional is considering use of HCQ or chloroquine to treat or prevent COVID-19, the FDA recommends that the physicians check www.clinicaltrials.gov for a suitable clinical trial, and consider enrolling the patient and consulting available resources to assess a patient’s risk of QT prolongation and mortality. The FDA specifically mentions that use of HCQ or chloroquine be limited to hospitalized patients, not for outpatients or for use in prophylaxis.

The most recent NIH COVID-19 Treatment Guidelines recommend that if chloroquine or HCQ is used, the patient must be monitored for adverse effects, especially prolonged QT intervals leading to ventricular arrhythmias, as mentioned previously. The Guidelines Panel recommends against the use of HCQ plus azithromycin outside the context of a clinical trial because of potential toxicities.

ACS Updates Guidelines for Triage and Management of Cancer Patients

Posted April 28, 2020

The American College of Surgeons (ACS) has updated the ACS Guidelines for Triage and Management of Elective Cancer Surgery Cases During the Acute and Recovery Phases of Coronavirus Disease 2019 (COVID-19) Pandemic to include additional information related to the care of prostate cancer patients.

The objective of this document is to continue to provide a framework for how providers can consider the many challenging aspects of cancer patients’ needs during the pandemic, including the acute phase, a time defined by governmental bans on elective surgery, and the recovery phase, when, no doubt, bans will be lifted and backlogs of patients will need urgent attention. Although most surgeons would not consider cancer surgery as elective, some cancer operations are more urgent than others, and this document provides some guidance on prioritization strategies that may be helpful. As before, the ACS Cancer Programs fully appreciate that nothing replaces sound medical judgment and that local conditions and resources will dictate how and when patients receive their care.

National Rural Health Association Responds to the Needs of Rural Health Care Providers

Posted April 28, 2020

Nearly half of all rural hospitals were operating at a financial loss before the COVID-19 pandemic, and today, the outbreak is adding to their financial stress through a lack of revenue typically brought in by nonemergency care. More specifically, the rate of rural hospital closures before the pandemic was already at a crisis level, according to the National Rural Health Association (NRHA). Since 2010, 128 rural hospitals have closed, and more facilities are expected to shutter because of reduced cash flow.

COVID-19 also is amplifying longstanding challenges facing rural health care providers, specifically shortages of emergency services personnel and the availability of technology and supplies, including personal protective equipment, ventilators, and testing capabilities.

In recent weeks, the U.S. Department of Health and Human Services has been distributing the $100 billion in emergency funds allotted in the Coronavirus Aid, Relief, and Economic Security (CARES) Act, with $30 billion going to hospitals and other health care providers starting April 10 to cover unreimbursed health care-related expenses or lost revenue related to COVID-19. The NRHA also is requesting that a proportional percentage of the $100 billion provider grant be given to rural providers, as they provide care to 20 percent of the U.S. population—a population that typically is older and has higher rates of comorbidities.

The NRHA continues to support rural providers to ensure they have the resources necessary to respond to the pandemic, including offering an online resource center, recommending best practices, and partnering with federal agencies to reduce regulatory barriers.

Royal College of Surgeons COVID-19 Update

Posted April 28, 2020

In response to the rapidly evolving situation with COVID-19, the Royal College of Surgeons of England is producing a special edition of its Colorectal Surgery Update to collate high-level guidance and policy and to point readers to available research. This newsletter covers topics such as detection and diagnosis, infection control and transmission, patient care, workforce issues, and mental health care well-being.

Promising Therapeutics

VA Study Shows Hydroxychloroquine Is of No Benefit to COVID-19 Patients

Posted April 24, 2020

Yet another study has emerged that shows no benefit to the addition of hydroxychloroquine only (HCQ) or with added azithromycin (HC + AZ) to the standard of care (SOC) in a large retrospective comparison from the Department of Veterans Affairs (VA) hospitals. The outcomes for a total of 368 hospitalized male patients in the VA system who were treated for COVID-19 between March 9 and April 11 were examined. The outcomes assessed were death or need for ventilator support. The risk of death was highest in the HC-only group compared with SOC. Risk for need for ventilator support was no different in the groups (HC, HC + AZ, SOC). Although it was a retrospective study, the data were derived from electronic health records, not administrative or billing claims.

Bruton Tyrosine Kinase Inhibitor May Ameliorate Cytokine Storm

Posted April 24, 2020

An interesting brief report in the American Society of Clinical Oncologists’ ASCO Post described the use of a Bruton tyrosine kinase (BTK) inhibitor to reverse critical pulmonary insufficiency in a patient with Waldenstrom’s macroglobulinemia. This report and commentary explain the potential role of such tyrosine kinase inhibitors and the mechanism by which they may ameliorate the cytokine storm present in many critically ill COVID-19 patients by inhibiting many of the pro-inflammatory cytokines released in this setting. The findings were first published as a letter to the editor of journal Blood.

New ACS COVID-19 Registry: Registration Now Open

Posted April 24, 2020

The American College of Surgeons (ACS) COVID-19 Registry is now available to all hospitals interested in collecting important clinical patient data for a disease about which little is known. Hospitals are now joining.

We ask that you participate in this very important initiative.

The registry gathers data on surgical and nonsurgical COVID-19 positive patients. The ACS COVID-19 Registry is a quality improvement program and has been officially granted non-human subject research status, which does not require institutional review board oversight.

Participation in the registry is free of charge.

The ACS COVID-19 Registry was developed with the input of several expert clinicians who are treating COVID-19 patients. In addition to patient demographics, variables are designed to allow ease of data collection and are based on relevant severity predictors, admission information, hospitalization information, therapies used, and discharge information, as well as other factors. All patients ages 18 and older may be tracked from hospital admission through discharge by participating hospitals.

With the decades of experience in data collection and because of the immediate importance, this registry was created in an expedited time frame to respond to the ongoing pandemic crisis. The data collection platform uses REDCap—a known system that all hospitals can easily access. Each hospital will have 100 percent access to their collected data, and the ACS will provide each participating hospital benchmarked data reports at interval time periods. This information will help hospitals to better understand their efforts and results in context to other facilities.

Again, we ask that you participate in this very important initiative. We all need to learn more about COVID-19 patients, and this ACS COVID-19 Registry will unequivocally help to advance our collective knowledge. Learn more about the ACS COVID-19 Registry, and contact COVID19Registry@facs.org to join.

University of Chicago Surgeons Offer Advice on Obtaining Informed Consent during COVID-19

Posted April 24, 2020

The department of surgery at the University of Chicago, IL, developed policy changes for obtaining informed consent from patients requiring surgery during the COVID-19 outbreak. These guidelines have been published in Annals of Surgery and call for the following: attending responsibility for obtaining consent, circulation of a conversation guide for use in discussions between attending surgeons and their patients, and standardized documentation regarding discussion of COVID-19.

The first element of the COVID-19 enhanced informed consent discussion concerns the lack of information on the true risks of otherwise “routine” procedures during the pandemic. Second, the authors advise surgeons to discuss the uncertain (but likely increased) risk of nosocomial infection with COVID-19. Third, the authors believe that it is important to inform patients that the COVID-19 pandemic has changed day-to-day hospital operations at many hospitals in ways that have the potential to significantly affect their perioperative care and experience. They also suggest that surgeons discuss the possible impact of pandemic-associated health care resource shortages on postoperative care.

NIH Issues Updated Guidelines on Treatment of COVID-19 Patients

Posted April 24, 2020

The National Institutes of Health (NIH) has issued updated treatment guidelines to inform clinical decision making when providing care to patients with COVID-19. Because clinical information about the optimal management of COVID-19 is evolving quickly, the NIH guidelines, which are crafted by a panel of experts in respiratory, infectious, and emergency patient care, are updated frequently as published data and other authoritative information becomes available. The latest iteration can be summarized as follows:

  • The COVID-19 Treatment Guidelines Panel does not recommend the use of any agents for pre-exposure prophylaxis (PrEP) against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) outside of the setting of a clinical trial.
  • The panel does not recommend the use of any agents for postexposure prophylaxis (PEP) against SARS-CoV-2 infection outside of the setting of a clinical trial.
  • The panel recommends no additional laboratory testing and no specific treatment for persons with suspected or confirmed asymptomatic or presymptomatic SARS-CoV-2 infection.
  • At present, no drug has proven to be safe and effective for treating COVID-19. The data are insufficient to recommend either for or against the use of any antiviral or immunomodulatory therapy in patients with COVID-19 who have mild, moderate, severe, or critical illness.

Study Shows Benefits of Self-Proning in COVID-19 ED Patients

Posted April 24, 2020

A pilot study carried out in a New York, NY, emergency department (ED) shows that awake early self‐proning improves oxygen saturation in COVID‐19-positive patients, according to a report published in Academic Emergency Medicine. The study included 50 patients suspected of having COVID-19 with hypoxia on arrival in the ED. A standard pulse oximeter was used to measure SpO2 (peripheral capillary oxygen saturation). SpO2 measurements were recorded at triage and after five minutes of proning. Supplemental oxygenation methods included non‐rebreather mask and nasal cannula. Investigators also characterized post‐proning failure rates of intubation within the first 24 hours of arrival to the ED.

Overall, the median SpO2 at triage was 80 percent (interquartile range [IQR] 69 to 85). After application of supplemental oxygen was given to patients on room air it was 84 percent (IQR 75 to 90). After five minutes of proning was added, SpO2 improved to 94 percent (IQR 90 to 95). Comparison of the pre- to postmedian by the Wilcoxon rank-sum test yielded P=0.001. A total of 13 patients (24 percent) failed to improve or maintain their oxygen saturations and required endotracheal intubation within 24 hours of arrival to the ED.

Further studies are needed to support causality and determine the effect of proning on disease severity and mortality.

JAMA Report on Mortality Rates for COVID-19 Patients on Ventilators: Incomplete Picture

Posted April 24, 2020

A recent study by Richardson and colleagues in the Journal of the American Medical Association (JAMA) has made national headlines for its report of an 88 percent mortality rate for COVID-19 mechanically ventilated patients in a New York, NY, area health system. Although the mortality rate of COVID-19 patients with acute respiratory distress syndrome is undoubtedly high, it is important to note that in this study, due to the limited follow-up period, the clinical outcomes are unknown overall for 54 percent of the patients. Of the 1,151 mechanically ventilated patients in the study, at a median follow-up period of 4.5 days, 3 percent had been discharged home, 25 percent had died, and 72 percent were still hospitalized, intubated, and mechanically ventilated. The reported mortality rate of 88 percent was calculated based on deaths and discharges of 320 out of 1,151 mechanically ventilated patients. The outcomes for the remainder 831 patients who remained intubated at the end of study will change the reported mortality rate, likely downward, though possibly even upward. Preliminary data from other centers suggests a mortality rate lower than the 88 percent reported by the study authors. More research clearly is needed.

Surgical Specialty Societies Offer Recommendations for Ramp Up of Elective Operations

Posted April 24, 2020

Most surgical specialty societies have not committed to a policy or time frame to resume elective surgery. The American Academy of Ophthalmology (AAO) and the American Academy of Orthopaedic Surgeons (AAOS) state on their websites that decisions to reopen normal practice should be made locally and regionally, not nationally, and should be based on available resources. The AAOS has developed clinical considerations, and the AAO is in the process of developing guidelines. Most of the societies refer their members to Centers for Medicare & Medicaid Services and American College of Surgeons guidelines.

More specific information is as follows:

Ophthalmologists Offer Recommendations on Eye Care during Pandemic

Posted April 24, 2020

A study published in Current Eye Research indicates that, to minimize COVID-19 infection of both health care personnel and patients, ophthalmologists should use nonpharmaceutical interventions, follow hygienic recommendations, and wear personal protective equipment to contain viral spread. The authors also suggest conducting risk assessment for postponement of nonurgent cases and triage for ophthalmic outpatient clinic. The study was conducted in Bergamo, Italy, an epicenter of the COVID-19 outbreak in Europe.

Resuming Elective Surgery at UTMB Predicated on Patient and Staff Well-Being

Posted April 24, 2020

J. Patrick Walker, MD, FACS, Professor, Minimally Invasive Surgery/Foregut Surgery Division, Department of Surgery; James C. Thompson, MD, Distinguished Chair in Surgery; Vice-Chair for Surgical Operations; and Surgical Director of Perioperative Services, University of Texas Medical Branch, Galveston, shares his health system’s experience during COVID-19. He also describes how the health system has sought to prepare to resume the provision of elective surgery. Read more here.

Promising Therapeutics

Posted April 21, 2020

Rheumatology Alliance Data Refute Claims that Hydroxychloroquine Prevents COVID-19

Global COVID-19 Rheumatology Alliance has been formed to gather data that has been examined to determine the clinical benefits for patients who were treated with hydroxychloroquine (HCQ), NSAIDs, azathioprine, and other drugs, including biologic disease-modifying therapies, that theoretically may alter susceptibility to COVID-19. Within one week, the Alliance was able to identify 110 patients with COVID-19 who have been prescribed these medications and found evidence refuting anecdotal claims that HCQ prevents the development of COVID-19. Click here for more information.

Study Shows Hydroxychloroquine Has Limited Impact on COVID-19

A preprint article reports on the largest randomized, controlled open-label trial on the use of HCQ in the treatment of COVID-19. The study, conducted in China, showed no difference in viral conversion (positive viral shedding) between HCQ and standard care, some decrease in inflammatory markers, and no significant difference in clinical symptom resolution or clinical outcome. Some concerns about the study include the following: performance of the study (a multicenter trial), use of other antiviral drugs was not controlled, entry into the study was an average of 16 days after initiation of symptoms (a relatively late date to start treatment), and some patients had diarrhea in the HCQ group (though the dosages used in the study were higher than many other studies). No adverse cardiac events were noted.

CMS Releases Guidelines for Restarting Non-COVID-19 Essential Care

Posted April 21, 2020

The Centers for Medicare & Medicaid Services (CMS) on April 19 issued the first phase of guidance to reopen health care systems in communities with low and stable incidence of COVID-19. The guidelines recommend a gradual transition to restart in-person care for patients with non-COVID-19 needs by encouraging physicians to evaluate the necessity of the care based on clinical needs and prioritizing surgical services and/or high-complexity chronic disease management. The agency urges health care facilities to consider establishing non-COVID care (NCC) zones to screen all patients and visitors—and routinely screen employees—for symptoms of COVID-19. CMS indicates that NCC zones should be designed to facilitate social distancing and should be located in buildings, on floors, or in rooms that have minimal crossover with COVID-19 areas. The agency notes that facilities and providers should collaborate with local and state public health officials to review the availability of personal protective equipment and other supplies, workforce availability, facility readiness, and testing capacity when making the decision to restart or increase in-person care. Contact regulatory@facs.org with questions.

Coagulation Abnormalities, Hypercoagulability, and Empiric Anticoagulation for Thromboembolism in COVID-19 Infection

Posted April 21, 2020

A number of recent studies have explored the connection between COVID-19 infection and coagulopathy, and over the last week it has become apparent that venous thromboembolic (VTE) disease is common in critically ill patients with severe COVID-19. This article describes how surgeons have developed a protocol to empirically anti-coagulate patients at highest risk/suspicion for VTE and to delay imaging until patient recovery. Click here to read more.

Analgesia and Sedation in Patients with COVID-19

Posted April 21, 2020

Approximately 14 percent of patients with COVID-19 infection experience a severe form of hypoxic respiratory failure, with 5 percent requiring mechanical ventilation.1 The dyspnea, air hunger, physical discomfort of being intubated, and possibility of self-extubation have made sedation of these patients challenging, with many requiring high doses of multiple medications to achieve comfort. Moreover, in the subset of patients with low lung compliance and acute respiratory distress syndrome, use of low tidal volumes, controlled ventilation, and prone positioning require high levels of sedation and often neuromuscular blockade to permit proper ventilation.2,3 Click here to read more.

COVID-19 and Increased Requirements for Sedation

Posted April 21, 2020

Surgeons and other physicians offer their recommendations for providing sedation and analgesia to COVID-19 patients. They also offer recommendations for using multimodal regimens to control to help limit the use of drugs that may be in short supply. Click here to read more.

Summary of CDC Mortality and Morbidity Weekly Report, 4-17-2020

Posted April 21, 2020

Both during the new COVID-19 crisis acutely and during the restart period after the initial wave of infections, knowledge of the disease’s effects on health care workers is an important element in the decision-making process. On April 17, the Centers for Disease Control and Prevention (CDC) reported in their Mortality and Morbidity Weekly Report findings from February 12 through April 9.

  1. In the reported time period, more than 315,000 reports of COVID-19 infections were filed.
  2. Only 16 percent of these forms had “health care personnel” (HCP) as a reported data point.
  3. A total of 9,282 reports were filed:
    1. 55 percent were infected by direct patient care contact
    2. 92 percent had symptoms
    3. 8 percent were asymptomatic
    4. 90 percent did not require hospitalization
    5. 10 percent had a severe illness
    6. 27 deaths were reported in this group
    7. All ages were affected with death more commonly in the <65-year-old group, but deaths did occur in all age groups
  4. The CDC points out that the number of affected HCP probably is underreported.
  5. Because outcomes evolve over time, the final outcome data cannot be determined in this report. The data are descriptive, not quantitative.

Read the full article.

Royal College of Surgeons COVID-19 Update

Posted April 21, 2020

In response to the rapidly evolving situation with COVID-19, the Royal College of Surgeons of England is producing special editions of its Colorectal Surgery Update to collate high-level guidance and policy and to point readers to available research. This newsletter covers topics such as detection and diagnosis, infection control and transmission, patient care, workforce issues, and mental health care well-being.

Lessons Learned About Ramp Up in New York, NY

Posted April 17, 2020

As the rest of the nation prepares for the number of COVID-19 cases to peak this month, trauma directors from New York, NY, hospitals and members of the American College of Surgeons Greater New York Chapter Committee on Trauma have developed an outline of the lessons learned from the experience and offer recommendations for ramping up intensive care unit (ICU) capacity. Specifically, the authors recommend prompt review of existing emergency department/trauma bay protocols, reallocation of staff and physical resources to the ICUs, and an integrated regional response plan. Read the full report here.

COVID-19 and Telemedicine: No Turning Back

Posted April 17, 2020

COVID-19 has fundamentally promulgated the use of telemedicine, and most likely telemedicine will be part of our surgical careers ever after the outbreak. This pandemic has forced people around the world to rethink how we interact socially and surgeons to reevaluate how we practice. The currency for health care traditionally was a face-to-face visit; now many surgeons have rapidly turned to telemedicine for their nonoperative work. This change happened in one month—March 2020. Once this sad time passes and we enter the new era of our society and health care, a large portion of our surgical practices, if not the majority, will be based on telemedicine. Surgeons have been through rapid technological change before, especially with the advent of minimally invasive surgery that radically transformed—for the better—patient outcomes and our ability to operate.

It is critical that we embrace telemedicine and make sure that we craft the future of telemedicine to enable surgeons and the American College of Surgeons in providing safe surgical care. Read more about telemedicine from Andrew Watson, MLitt, MD, FACS, University of Pittsburgh Medical Center, Presbyterian Shadyside Hospital, PA.

Additional Telehealth Resources

Healthline’s Best Telemedicine Apps of 2019

Software Advice: Telemedicine Software

Mundaii, a web-based free-market platform for health care opinions and services

AAMC Releases New Guidance on Medical Student Participation in Direct Patient Contact Activities

Posted April 17, 2020

The Association of American Medical Colleges (AAMC) on April 14 released updated guidance on the participation of medical students in patient care activities. The overall message remains the same as in previous guidance – for medical schools within areas that have significant active or anticipated community spread of COVID-19, and/or limited availability of personal protective equipment (PPE), and/or limited availability of COVID-19 testing, the AAMC recommends that medical students not be involved in direct patient care activities, unless an institution is experiencing a critical workforce shortage.

The updated guidance provides specific additional recommendations for medical schools that are experiencing a critical workforce shortage to keep their volunteer medical students as safe as possible. These new recommendations include reviewing medical students’ health insurance information to ensure that volunteering to serve during the pandemic does not preclude them from coverage, making certain that sufficient PPE is available for the medical student volunteers to have consistent access, and ensuring COVID-19 testing is readily available to students and that any increase in positive tests among trainees is monitored and reacted to accordingly.

Early Data Show that COVID-19 Wreaks Havoc on Multiple Organs

Posted April 17, 2020

Clinicians and researchers are finding that COVID-19 not only kills by inflaming and clogging the tiny air sacs in the lungs, thereby choking off the body’s oxygen supply, but it also can cause heart inflammation, acute kidney disease, neurological malfunction, blood clots, intestinal damage, and liver problems.

That development has complicated the treatment of the most severe cases of COVID-19, the illness caused by the virus, and makes the course of recovery less certain, physicians say in an article published this week in The Washington Post. The prevalence of these effects is too great to attribute solely to the “cytokine storm.” For example, early data show that 14 to 30 percent of intensive care patients in New York, NY, and Wuhan, China, lose kidney function and require dialysis or continuous renal replacement therapy.

Society of Gynecologic Oncology Reassignment Recommendations

Posted April 17, 2020

Because of the rising burden of COVID-19 on institutions throughout the country, the Society of Gynecologic Oncology (SGO) is offering guidance to their members to help them discuss their potential reassignment outside the practice of obstetrics and gynecology.

Whereas SGO members have responsibilities that preclude their reassignment—such as obligations to see new urgent and emergent cancer cases, overseeing ongoing chemotherapy and radiation of patients, and assisting gynecology colleagues with surgical emergencies—the SGO has recommendations regarding where gynecologic oncologists can be used to assist other medical and surgical staff. Read about the back-up and support recommendations here.

Guidance on Tracheostomy during the COVID-19 Pandemic

Posted April 17, 2020

As the COVID-19 pandemic evolves, acute care surgeons, intensivists, and other surgical specialists increasingly may be asked to perform a tracheostomy in patients with known or suspected coronavirus-19 infection. To help surgeons prepare for this inevitability, the Critical Care and Acute Care Surgery Committees of the American Association for the Surgery of Trauma (AAST) have developed guidance and recommendations on how to perform the procedure safely in altered or suboptimal conditions and protect themselves and other health care personnel from undue risk of exposure and infection.

The guidance documents are published in Trauma Surgery and Acute Care Open, with leaders of the AAST and the Committee on Trauma of the American College of Surgeons as authors. The authors note that tracheostomy has many known benefits in critically ill and injured patients, but its utility in the recovery of patients with COVID-19 is unknown. Furthermore, the procedure poses a significant risk of viral transmission because it is an aerosol-generating procedure. The document recommends that surgeons consider both short- and long-term outcomes of tracheostomy along with the risks of exposure of the clinical team.

Association of Coloproctology of Great Britain and Ireland Releases Guidance on Surgery for IBD during the COVID-19 Pandemic

Posted April 17, 2020

The Association of Coloproctology of Great Britain and Ireland (ACPGBI) has released guidance on surgery for patients with irritable bowel disorder (IBD) during the COVID-19 pandemic. The guidance document notes that surgery is recognized as the treatment of choice for some specific complications of IBD in order to save lives and improve quality of life. The document encourages the use of multidisciplinary teams in clinical decision making, consideration of the severity of patients’ illness, and strong stewardship of hospital resources during the pandemic. The guidance document can be accessed here.

Spanish-Language Video Demonstrates How to Manage the Airway

Posted April 17, 2020

Clinica Universidad de los Andes has produced a short Spanish-language video on airway management in COVID-19 patients. The techniques used in this simulated demonstration are based on those outlined in the American College of Surgeons Committee on Trauma’s Advanced Trauma Life Support® course.

Promising Therapeutics

Study Weighs the Benefits of Use of Remdesivir in Critically Ill Patients

Posted April 14, 2020

A newly published article in the New England Journal of Medicine reports on a small study of compassionate use of remdesivir in severely ill COVID-19 patients. Sponsored by the manufacturer—Gilead—the study was open-label, non-randomized, and non-controlled, which is interesting because this drug is currently in wide use. The study observes that clinical improvement was seen in 36 of 53 patients (68 percent) treated with remdesivir and calls for a randomized, controlled study.

Debate Regarding Use of Hydroxychloroquine Continues

Posted April 14, 2020

The ongoing debate on use of chloroquine and hydroxychloroquine in the treatment of COVID-19 patients has become even more controversial with the publication of a small Brazilian study of high-dose chloroquine (12 grams total dose over 10 days) versus lower dose (total dose of 2.7 grams over five days) that showed higher cardiac toxicity (more prolongation of corrected QT interval [QTc] > 500ms and a trend to higher mortality). Confounding the results was the concomitant use of azithromycin in all these patients, which can also prolong QTc and cause cardiac arrhythmias. The high-dose treatment arm was halted prematurely because of the potential safety hazard. The study also showed a low clearance rate of respiratory virus in only one of 14 patients (7 percent).

Convalescent Plasma May Be Useful in Prevention and Treatment

Posted April 14, 2020

A viewpoint article was published in the Journal of Clinical Investigation describing the use of convalescent plasma for prophylaxis and therapy. The authors argue that human convalescent plasma is an option for prevention and treatment of COVID-19 disease that could be rapidly available when there are sufficient numbers of people who have recovered and can donate immunoglobulin-containing plasma.

Update on Hydroxychloroquine

Posted April 10, 2020

Though many surgeons are unlikely to prescribe hydroxychloroquine (HCQ) for COVID-19 patients, it is important for us to be aware of the ongoing controversy surrounding this drug.

The recent French study from Marseille, which showed rapid clearance of SARS-CoV-2 with the use of HCQ, is now under question.

The International Society of Antimicrobial Chemotherapy (ISAC), which is not the publisher of the journal in which the article was published, states the article “does not meet the expected standard, especially relating to the lack of better explanations of the inclusion criteria and the triage of patients to ensure patient safety,” as cited on the website Retraction Watch (with further discussion). The ISAC statement is found here.

Given the lack of thoroughly conducted studies on HCQ, the ACS can neither endorse the use of the drug in COVID-19 patients, nor can we reliably discourage its use.

Interesting Developments in the Use of Convalescent Plasma

Posted April 10, 2020

A consortium of more than 50 hospitals and universities has created the National COVID-19 Convalescent Plasma Project to pool efforts to investigate the use and efficacy of convalescent plasma from COVID-19 patients who recovered from the disease. The use of convalescent plasma has been used in SARS, Ebola, and historic cases of polio and mumps.

The Food and Drug Administration (FDA) designated the Mayo Clinic to be the lead institution to provide coordinated access to the use of convalescent plasma for hospitalized COVID-19 patients with severe or life-threatening disease on April 3.

Additionally, the FDA issued guidance to health care providers on April 8 on the administration and study of convalescent plasma.

This use is restricted to patients with severe or life-threatening disease as defined by:

  • Laboratory-confirmed COVID-19
  • Severe or immediately life-threatening COVID-19, for example,
    • Severe disease is defined as one or more of the following:
      • shortness of breath (dyspnea),
      • respiratory frequency ≥ 30/min,
      • blood oxygen saturation ≤ 93%,
      • partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300,
      • lung infiltrates > 50% within 24 to 48 hours
    • Life-threatening disease is defined as one or more of the following:
      • respiratory failure,
      • septic shock, multiple organ dysfunction or failure

Further information is available here.

Current publications include:

Report of five patients with severe COVID-19 treated with convalescent plasma with improvement

Report of 10 patients with severe COVID-19 patients with safety, efficacy, and reduction in viral load

This is an exciting and interesting approach for those experiencing severe COVID-19 and is worth considering, if possible.

Hydroxychloroquine

Posted April 8, 2020

The use of hydroxychloroquine (HCQ) and azithromycin for COVID-19 disease continues to be a hotly debated issue. It is being used widely, but the data supporting efficacy and safety is very limited. It has been advocated in small studies and discouraged in others. A recent French study from Paris shows no increase in viral clearance in COVID-19 patients and no improvement in clinical outcome in a limited series of 11 patients treated with both HCQ and azithromycin. This outcome is in contrast to another recent French study from Marseille that showed rapid clearance of SARS-CoV-2 with the same drug regimen.

In this edition, we provide an update on promising therapeutic options. To that end, an article in the April 6 issue of the Wall Street Journal notes that more than 140 experimental drug treatment and vaccines for the coronavirus are in development worldwide. Most of these therapeutics are in the early stages of testing, with 11 already in clinical trials. In all, including drugs approved for other diseases, 254 clinical trials are testing treatments or vaccines for the virus—many spearheaded by universities and government research agencies.

Emerging Treatment Protocols and Issues Surrounding Unique Aspects of COVID-19 Patients

Posted April 14, 2020

As physicians gain more experience with COVID-19 patient management, treatment protocols and issues surrounding the unique aspects of these patients are becoming available. Among those issues are management of COVID-related acute respiratory distress syndrome (ARDS), management of COVID coagulopathy and its treatment, as well as specific issues surrounding cardiopulmonary resuscitation (CPR) in this highly contagious disease. The critical care group at Stony Brook, NY, gave an early report on use of anticoagulants in managing the COVID patient. Also, Lena M. Napolitano, MD, FACS, FCCP, FCCM, has provided the University of Michigan’s presentation  on the worldwide experience in COVID patient management. Finally, Dr. Lang offers a bullet-point summary and real-world tips on ventilation and the issues of CPR at the University of Washington Medical Center in Seattle.

Anticoagulation Strategies in Patients with COVID-19 Infection: Brief Commentary

Posted April 14, 2020

Retrospective reviews of COVID-19 patients in China show that patients with severe infection developed disseminated intravascular coagulation, as reflected by elevated D-dimer, prolonged prothrombin time/international normalized ratio, partial thromboplastin time, decreased fibrinogen, and thrombocytopenia.

Of note, elevated D-dimer with three- to fourfold increase may be prognostic for severe COVID-19 infection, indicating the necessity for admission. Autopsy reports show microthrombi in the pulmonary vasculature, which may be an explanation for the acute respiratory distress syndrome-like clinical presentation.1,2 Tang and colleagues observed a decreased mortality rate in their cohort of patients who received anticoagulant treatment, primarily with low-molecular-weight heparin (LMWH),) during their clinical course.3 The increased risk of venous thromboembolism in severe COVID-19 is unclear.

The International Society of Thrombosis and Haemotology (ISTH) has provided interim guidance for management of COVID-19 coagulopathy based on these early reports from Wuhan, China.4 Current recommendations are for all COVID-19-positive patients to be treated with LMWH prophylaxis. Fondaparinux is recommended for patients with increased risk for bleeding. Therapeutic anticoagulation in COVID-19 is indicated only when a venous thromboembolism (VTE) is present or when a patient has been on anticoagulation for pre-existing VTE or atrial fibrillation. Additional guidance can be reviewed in this article. In our experience, we have seen COVID-19-positive patients clotting renal replacement circuits, lines, and some anecdotal experience in increasing VTEs. More data are needed to develop standardized care for these patients. We are learning as we go, and this process is fluid in nature.

References

  1. Luo W, Yu H, Gou J, Li X, Sun Y, Li J, Liu L. Clinical pathology of critical patient with novel coronavirus pneumonia (COVID-19). Preprints. 2020.
  2. Chen N, Zhou M, Dong X, et al. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: A descriptive study. Lancet.2020;395: 507-513.
  3. Tang N, Bai H, Chen X, Gong J, Li D, Sun Z. Anticoagulant treatment is associated with decreased mortality in severe coronavirus disease 2019 patients with coagulopathy. J Thromb Haemost.2020.
  4. Thachil J, Tang N, Gando S, et al. ISTH interim guidance on recognition and management of coagulopathy in COVID-19. J Thromb Haemost. 2020.

University of Miami Study Discusses Potential Uses of Anticoagulation in COVID-19 Patients

Posted April 14, 2020

Members of the University of Miami’s division of trauma surgery and surgical critical care team have published a review of anticoagulation use and recommendations for the treatment of a hypercoagulable state in those affected by COVID-19. The use of an anticoagulant appears to be associated with decreased mortality in all patients, but, more specifically, the use of heparin is discussed because of its anticoagulant, anti-inflammatory, and potential antiviral properties. Read the full report here.

Expert Medical Societies Release Multidisciplinary Recommendations for Breast Cancer Patient Care During COVID-19 Pandemic

Posted April 14, 2020

The American Society of Breast Surgeons, the National Accreditation Program for Breast Centers, the National Comprehensive Cancer Network, the Commission on Cancer of the American College of Surgeons, and the American College of Radiology® have released new joint recommendations for prioritization, treatment, and triage of breast cancer patients during the COVID-19 pandemic.

University of Chicago Team Offers New System to Prioritize Operations

Posted April 14, 2020

A team of investigators at the University of Chicago, IL, has devised a new scoring system that helps surgeons across surgical specialties decide when to proceed with medically necessary operations in the face of the resource constraints and increased risks posed by the COVID-19 pandemic. The process, called Medically Necessary Time-Sensitive (MeNTS) Prioritization, is published as an “article in press” on the Journal of the American College of Surgeons website ahead of print.

The MeNTS Prioritization process was created by a team of six representatives from general surgery, vascular surgery, surgical oncology, transplantation, cardiac surgery, otolaryngology, and surgical ethics. The team reviewed studies of the effect of COVID-19, as well as severe acute respiratory syndrome on hospital resources, health care providers, surgical procedures, and surgical patients in Asia and Europe and identified 21 factors related to outcome, risk of viral transmission to health care professionals, and use of resources.

Medically necessary time sensitive procedures: scoring system to ethically and efficiently manage resource scarcity and provider risk during the COVID-19 pandemic

Gastrointestinal Societies Offer Guidance on Endoscopy

Posted April 14, 2020

Several gastrointestinal (GI) health care organizations released a guidance document April 13 on “Management of Endoscopes, Endoscope Reprocessing, and Storage Areas during the COVID-19 Pandemic.” The joint GI society document provides best practice recommendations on disinfection, handling, and storage and provides guidance for resumption of elective endoscopy.

Low-Resource, Effective Method for Smoke Evacuation in Laparoscopic Surgery for COVID-19 Patients

Posted April 10, 2020

Potential transmission of the COVID-19 virus to surgical staff during aerosol-generating procedures, including laparoscopic surgery, is a growing concern as more operations on suspected or confirmed COVID-19 patients will be required. Although COVID-19 has not yet been documented in surgical smoke, surgeons must use precautions to reduce the risks to operating room (OR) staff while being cognizant of new and continuing resource limitations.

Annals of Surgery has released a brief piece from European surgeons and the European Association for Endoscopic Surgery (EAES) technology committee on the use of a simple, low-cost filtration system made from standard OR equipment that can be implemented immediately. The passive system uses standard electrostatic filters connected via standard tubing to the trocar evacuation port to constitute an evacuation and filtering system, which evacuates the generated smoke and filters the potential viral load. Members of the EAES technology committee found the system quick to assemble and effective in evacuating surgical smoke.

Precautions for CPR in COVID-19 Pandemic Conditions

Posted April 10, 2020

Questions continue to arise regarding clinical and ethical decisions during the COVID-19 pandemic. Among the most wrenching are decisions regarding end-of-life maneuvers such as cardiopulmonary resuscitation (CPR). Decisions regarding CPR are best planned before events occur and with the added consideration of risk to the individuals performing CPR. The biologic hazard to the individuals administering CPR gives an uncommon dimension to these decisions in pandemic conditions.

Throughout this epidemic, patients and their families must trust that CPR will be administered fairly and without restraint to all patients for whom such treatment is both effective and protects the public’s health. Megan Applewhite, MD, MA, FACS, and John A. Balint, MD, Alden March Bioethics Institute of Albany Medical College, NY, have developed an ethical framework to guide decision-making regarding allocation of scarce resources for adult patients in the event that the need for such resources exceeds supply—Allocation of Scarce Resources in Crisis. The benefits and risks of performing CPR are discussed, with the judgment falling to the clinician based on appropriate personal protective equipment (PPE) resources. To read more about CPR guidance during the COVID-19 pandemic, click here.

Further perspective on this issue can be found in two contemporary articles from the British Medical Journal (here and here) and an on-the-ground observation from Anthony J. Vine, MD, FACS, Assistant Clinical Professor of Surgery, Icahn School of Medicine at Mount Sinai Hospital, New York, NY, and member of the American College of Surgeons Board of Governors, who is working in COVID-19 wards at his institution.

Recommendations from the Alden March Bioethics Institute of Albany Medical College

[Given] the progressive nature of COVID-19, early discussion with patients and their families with documentation is critical to gaining an understanding of their goals of care. Patients and their families must be informed that if CPR is necessary and determined to be appropriate, it will be delayed until all providers on the code team have adequate PPE in place and are available to participate.

As is true with any patient, if the clinician determines that the patient is likely to clinically benefit from CPR such that the benefits outweigh the risks of exposure of faculty and staff, it is reasonable to proceed with CPR, but only after the appropriate PPE has been put into place.

If the cardiopulmonary arrest is [because of] progression of the COVID-19 infection, and the risks to providers outweigh the benefits of performing CPR (thus effectively making them unavailable to participate), then CPR should not be performed. These clinical judgments take priority over the requests of a patient’s legally authorized representative.

Dr. Vines’ Observations on CPR

Important points regarding CPR in the field are as follows:

  • Extra or impermeable personal protective equipment (PPE) and a good face shield are important.
  • The caregivers’ protection is paramount.

When using a self-inflating resuscitator (ambu bag), a high-efficiency particulate air (HEPA) filter must be attached. Unlike one anesthesiologist holding the mask with one hand and bagging with the other, this process takes two to three people: one or two must create an airtight seal around the patient’s nose and mouth.

  • It is wise to cover the patient’s face with a sheet or towel, while trying to get the oxygen (O2) set up to or above 70 and to gather ALL of the equipment (suction, defibrillator, wall O2 or a full O2 tank, and so on) and whatever drugs may be needed, rather than running for items chaotically.
  • If the glide scope and/or video laryngoscope are ready, then we place an endotracheal tube, and place the ambu bag with HEPA filter until the respiratory therapist/ventilator arrive.
  • The patient’s face (nose, especially) should be covered to prevent aerosolization of virus.
  • After the event, all involved should doff used PPE, scrub hands, wash face, and so on, and then don fresh PPE.

Are COVID-19-Related Pulmonary Insufficiency and ARDS Different Diseases?

Posted April 10, 2020

Early recommendations for acute respiratory distress syndrome (ARDS) ventilator strategies during the COVID-19 pandemic have been to follow the National Institutes of Health (NIH) ARDSNET protocol with high positive end-expiratory pressure (PEEP) and low tidal volume management. In a recent letter to the editor of the American Journal of Respiratory and Critical Care Medicine, Gattinoni and colleagues from Milan, Italy, shared their experience and observations, which recommend consideration of a different view of the lung physiology with COVID-19 infection.1 They noted that patients with COVID-19 lung physiology may differ with respect to high lung compliance, which is not seen in severe ARDS.

Typical ARDS lung compliance is decreased, which means a loss of alveolar volume--hence the strategy of alveolar recruitment in management of severe ARDS management.

Conversely, Gattinoni and colleagues found higher lung compliance in their small group of patients and a higher ratio of shunt fraction to fraction of gasless tissues, which suggested a hyperperfusion of gasless tissues. They recommend giving consideration to the redistribution of perfusion via gravitational mechanism. This observation may explain the trend toward delayed intubation with awake proning and high-flow nasal cannula supplementation. This modification in management will help to alleviate the shortage of ventilators while providing sustainable supportive care. Anecdotal reports also encourage AVOIDING high PEEP to start and to titrate to saturation/oxygenation. These observations are in line with the evolving management recommendations to individualize care as needed.

In our limited experience, a combination of early intubation, early renal replacement therapy, maintaining strict euvolemia and the use of airway pressure release ventilation, has been successfully used to treat these patients.2 We look forward to getting more data so we can make informed decisions that can benefit ARDS patients.

References

  1. Gattinoni L, Coppola S, Cressoni M, Busana M, Rossi S, Chiumello D. Covid-19 does not lead to a “typical" acute respiratory distress syndrome. Am J Respir Crit Care Med. Available at: https://www.atsjournals.org/doi/10.1164/rccm.202003-0817LE. Accessed April 9, 2020.
  2. Sun X, Liu Y, Li N, You D, Zhao Y. The safety and efficacy of airway pressure release ventilation in acute respiratory distress syndrome patients: A PRISMA-compliant systematic review and meta-analysis. Medicine (Baltimore). 2020;99(1):e18586. doi: 10.1097/MD.0000000000018586.

Overcoming Inequities in the Treatment of COVID-19 Patients

Posted April 10, 2020

Early data from the COVID-19 pandemic have shown that African-American patients suffer a disproportional burden of this crisis. Outcomes in metropolitan areas demonstrate stark differences in both incidence and death rates. For example, the incidence of COVID-19 for African Americans in Chicago, IL, is 317.1 per 100,000, whereas for whites it is 120.1 per 100,000. Similarly, the death rate for these populations was 16.8 per 100,000 and 2.8 per 100,000, respectively.1 A recent brief from New York City Health, NY, showed a 94 percent higher age-adjusted death rate for African Americans relative to whites.2 The toll of this devastating crisis is evidenced by the fact that African Americans accounted for 70.48 percent of COVID-19-related deaths in Louisiana.3

There are myriad reasons for the aforementioned differences in infection rates and outcomes. Mounting evidence suggests that systematic inequities play vital roles in driving health disparities. Consequently, minority patients have disproportionate rates of chronic diseases, including asthma, hypertension, and diabetes, all of which contribute to the lethality of COVID-19. Furthermore, evidence is emerging that environmental conditions, including low socioeconomic status and early stress exposure, influence the epigenomic programming in immune cells, thereby impacting immune responses to a host of biologic insults.4-7 Future investigations should focus on understanding the influence of structural violence on the immunobiology of anti-COVID-19 responses in African-American patients. This work will help determine the contribution of immunobiology to disparities in COVID-19 outcomes, and further will serve as a platform for novel therapeutic interventions for this disease.

Community outreach and engagement efforts will be critical to improving COVID-19 outcomes in African Americans. We must first encourage adherence to social distancing recommendations to help stem the spread of the virus. We also must expand access to COVID-19 testing to communities that lack appropriate diagnostic resources. These efforts will require multilevel and interdisciplinary partnerships between health systems and community stakeholders to engage minority patients in large-scale testing efforts. Finally, we must ensure that African-American patients have access to the latest treatments and are enrolled in clinical trials when diagnosed with COVID-19.

The COVID-19 pandemic has cast a glaring light on ongoing inequities in U.S. health care. This tremendous challenge offers us the opportunity to form new partnerships with epidemiologists, dissemination and implementation scientists, virologists, immunologists, and community engagement experts to address disparities in COVID-19 outcomes. The American College of Surgeons stands ready to approach these issues through ongoing research, advocacy, and education.

References

  1. COVID-19 latest data. Chicago Department of Public Health. Available at: https://www.chicago.gov/city/en/sites/covid-19/home/latest-data.html. Accessed April 10, 2020.
  2. COVID-19 Deaths by race and ethnicity. New York City Health. Available at; https://www1.nyc.gov/assets/doh/downloads/pdf/imm/covid-19-deaths-race-ethnicity-04082020-1.pdf, Accessed April 10, 2020.
  3. Coronavirus (COVID-19). Louisiana Department of Health. Available at: http://ldh.la.gov/Coronavirus, Accessed April 10, 2019.
  4. McDade TW, Ryan CP, Jones MJ, et al. Genome-wide analysis of DNA methylation in relation to socioeconomic status during development and early adulthood. Am J Phys Anthropol. 2019; 169(1):3-11.
  5. Gottschalk MG, Domschke K, Schiele MA. Epigenetics underlying susceptibility and resilience relating to daily life stress, work stress, and socioeconomic status. Front Psychiatry. 2020;March 20;11:163. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7099635/. Accessed April 10, 2020.
  6. Austin MK, Chen E, Ross KM, et al. Early-life socioeconomic disadvantage, not current, predicts accelerated epigenetic aging of monocytes. Psychoneuroendocrinology. 2018; 97(11):131-134.
  7. McDade TW, Ryan C, Jones MJ, et al. Social and physical environments early in development predict DNA methylation of inflammatory genes in young adulthood. Proc Natl Acad Sci USA. 2017; 114(29):7611-7616.

CT Reveals Asymptomatic Patient Is COVID-19 Positive

Posted April 10, 2020

COVID-19 patients sometimes are asymptomatic. Surgeons and other physicians who are providing follow-up care have opportunities to uncover the disease in their patients and refer them for early treatment. For example, an assistant professor, thoracic and cardiovascular surgery, University of Texas MD Anderson Cancer Center, Houston, ordered computed tomography (CT) for an asymptomatic cancer survivor who had come in for surveillance cancer screening imaging. The imaging showed bilateral ground glass findings. The patient tested positive for COVID-19. Incidental findings such as this suggest the limitations in our awareness of infection rates.

American Enterprise Institute Issues Road Map for Transitioning to Life After COVID-19

Posted April 10, 2020

The American Enterprise Institute has issued a road map for navigating the COVID-19 outbreak in the U.S. It outlines specific directions for adapting our public health approach away from sweeping mitigation strategies as we limit the epidemic spread of COVID-19, so that health care providers can transition to new tools and approaches to prevent further spread of the disease.

The authors outline the steps that can be taken as epidemic transmission is brought under control in different regions. They also suggest measurable milestones for identifying when civic leaders can make these transitions and encourage their communities to resume normal business, cultural, and recreational activities. In each phase, the authors outline the steps that the federal government, working with the states and public health and health care partners, should take to inform the response. This strategy will take time to implement; however, planning for each phase should begin now so the infrastructure is in place when it is time to transition, according to the report.

Expert Consensus Sought to Prioritize Research Topics

Posted April 10, 2020

A new study is being conducted to determine surgical research priorities associated with the COVID-19 pandemic. More specifically, researchers are soliciting surgeons and other stakeholders to submit relevant research questions and topics by completing this survey. Researchers also will engage relevant patient groups for their input. The study comprises three rapid phases in order to evaluate and rank the surgical research priorities and is endorsed by the Association of Upper Gastrointestinal Surgery of Great Britain and Ireland; PanSurg, a U.K-based collaborative of clinicians, and the World Society of Emergency Surgery.

Michigan Collaborative Provides Extensive Best Practices for COVID-19 and Critical Care Patients

Posted April 8, 2020

As the case volume of COVID-19 patients continues to surge in the U.S. and globally, surgeons and other professionals are seeking easy-to-access information on how to provide quality care to these individuals. The Michigan Critical Care Collaborative Network (MCCCN)—a statewide collaboration of health care professionals managing COVID-19 patients—has developed a repository of best practices gleaned from lessons learned around the world. These resources include information on frontline provider treatment tips, intensive care unit (ICU) medications, airway and respiratory therapy, emergency general surgery and operating room management of COVID-19 patients and persons under investigation, and guidance for personal protection equipment for wards, ICUs, and the trauma bay.

Role of Prone Positioning in Management of COVID-19-Related ARDS

Posted April 8, 2020

Randomized prospective trials and observational studies involving patients with Adult Respiratory Distress Syndrome (ARDS) have shown improved outcomes with the use of prone positioning. Information and resources that may be useful for surgeons called upon to care for patients with COVID-19-related ARDS can be accessed here.

A useful review of available data appeared in an article by Scholten and coauthors in Chest, 2017;1 a link to the full-text article is provided here. The article contains a useful discussion of beneficial physiologic changes that occur when patients with ARDS are placed in the prone position. The weight of the heart and abdominal viscera on the dorsal segments of the lung is reduced and this permits improvements in distribution of inspired gases. This redistribution also prevents alveolar de-recruitment and improves results of maneuvers for alveolar recruitment. Concomitant changes in cardiac function result in more uniform distribution of pulmonary blood flow.2 The overall result is improved oxygenation, increases in lung compliance, and more uniform distribution of ventilation.

The authors noted that the optimum duration of prone positioning is unclear; they recommended patient proning be continued for 16 hours/day until pulmonary variables were consistently improved, and that improvement was maintained when the supine positioning was resumed (see summary table referenced below). Other approaches to the duration of prone positioning may be appropriate in patients that require, for example, wound care, management of an open abdomen, etc. In these settings, shorter periods (e.g., six hours) repeated during the day are effective. Some challenges that arise during the use of prone positioning include increased secretion production due to recruitment of fluid-filled alveoli. Protocols for management of analgesia/sedation will be needed when prone positioning is used. A comprehensive source offering advice to health care professionals who are managing critically ill patients with COVID-19 infection has been produced by the Michigan Critical Care Collaborative.

Summary Recommendations for Prone Ventilation

The authors cited data from one large prospective trial showing that prone positioning not only improves oxygenation, but also lowers mortality in patients with moderate-severe ARDS. Other data cited in the review documented adverse effects of prone positioning in obese patients; in this patient group, prone positioning increased intra-abdominal pressure. The authors suggested that abdominal pressure monitoring may be useful along with measures to monitor gastric residual volumes. The authors emphasized the need for caution when considering use of prone positioning in obese patients with ARDS. If prone positioning is used, placing the obese patient in reverse Trendelenburg position has been shown to facilitate monitoring, gastric emptying, and management of abdominal hypertension.

A summary table that lists the indications for prone positioning, recommendations for safe positioning, and criteria for stopping the intervention is available below.

Major Trials of Prone Ventilation in ARDS

Prone positioning may also be useful for reducing the risk of progression to endotracheal intubation and ventilator support in patients with ARDS. A study by Ding and coauthors3 showed that combining prone positioning with high flow nasal cannula oxygen delivery or other forms of noninvasive ventilation reduced the risk of intubation and ventilator management in patients with moderate-severe ARDS.

The fact that placing patients with ARDS in the prone position requires careful protection of the airway and necessitates use of several staff members may be a daunting prospect in times of staff shortages because of the increased patient loads associated with the COVID-19 pandemic. Data are available, however, showing that implementation of a prone positioning protocol is cost effective and associated with significant patient benefit.4

A useful review of prone positioning that includes a video depicting a safe method for proper positioning of a patient is available on Twitter and can be accessed using this link.

References

  1. Scholten EL, Beitler JR, Prisk GK, Malhotra A. Treatment of ARDS With Prone Positioning. Chest. 2017;151(1):215-224.
  2. Saran S, Gurjar M, Azim A, et al. Trans-Esophageal Doppler Assessment of Acute Hemodynamic Changes Due to Prone Positioning in Acute Respiratory Distress Syndrome Patients. Shock. 2019;52(4):e39-e44.
  3. Ding L, Wang L, Ma W, He H. Efficacy and safety of early prone positioning combined with HFNC or NIV in moderate to severe ARDS: a multi-center prospective cohort study. Crit Care. 2020;24(1):28.
  4. Baston CM, Coe NB, Guerin C, Mancebo J, Halpern S. The Cost-Effectiveness of Interventions to Increase Utilization of Prone Positioning for Severe Acute Respiratory Distress Syndrome. Crit Care Med. 2019;47(3):e198-e205.

Management of Symptomatic Gallbladder Disease and Acute Cholecystitis during the COVID-19 Pandemic

Posted April 8, 2020

Click here to read guidance on management of symptomatic gallbladder disease during the COVID-19 pandemic is to ensure that surgeons can accomplish the following:

  • Provide the best surgical care possible for non-COVID-19 patients with gallbladder disease.
  • Limit exposure of all patients to the coronavirus.
  • Limit exposure of health care workers to the coronavirus.
  • Preserve resources to care for coronavirus patients.

COVID-19 Treatment Updates from the Front Lines in New Orleans

Posted April 8, 2020

David Janz, MD, a critical care medicine specialist at University Medical Center New Orleans (UMCNO), LA, outlines the treatment protocol UMCNO is using to treat critical COVID-19 patients. The video addresses treatment of COVID-19 for respiratory distress. Watch the 45-minute video.

JACS Article Describes Tiered Surgical Response Plan for COVID-19

Posted April 8, 2020

The acute care division at Atrium Health’s Carolinas Medical Center, Charlotte, NC, has developed a tiered plan for marshaling limited resources during the COVID-19 pandemic. The article posted in the Journal of the American College of Surgeons (JACS)—"Maximizing the calm before the storm: A tiered surgical response plan for COVID-19”—focuses on acute care surgeon deployment, recommended infrastructure and transfer utilization, triage principles, and faculty, resident, and advanced care practitioner deployment.

National Academies of Sciences, Engineering, and Medicine Provides Standards of Care Guidance

Posted April 8, 2020

To support crisis standards of care (CSC) decision making at all levels, the National Academies of Sciences, Engineering, and Medicine (NASEM) has released a rapid expert consultation document outlining core principles of CSC planning and implementation. Developed by NASEM’s Standing Committee on Emerging Infectious Diseases and 21st Century Health Threats, this document was based on the previous decade of National Academies reports and underscores a primary principle of CSC—achieving the best outcomes for a group of patients rather than focusing on an individual patient.

The key elements of CSC planning include ethical grounding; engagement, education, and communication; legal considerations; indicators, triggers, and responsibilities; and evidence-based clinical operations. The NASEM document includes an appendix with examples of shortages that can trigger CSC.

Implementing CSC planning is facilitated, in part, by COVID-19 emergency declaration blanket waivers released by the Centers for Medicare & Medicaid (CMS). The waivers, retroactive to March 1, allow hospitals to establish additional treatment locations, expand access to telehealth, permit additional workforce capacity, and eliminate some administrative requirements.

University of Nebraska Medical Center Releases New Perioperative Procedure Maps

Posted April 8, 2020

The University of Nebraska Medical Center (UNMC) April 3 released recent updates to its guidelines for decision making in the perioperative management of patients who require anesthesia and surgical services. These guidelines were developed with the evolving prevalence of COVID-19 in mind and in the context of responsible use and availability of personal protective equipment.

Deployment of Surgeons for Out-of-Specialty Patient Care

Posted April 8, 2020

The COVID-19 pandemic has inflicted unprecedented stresses upon health care institutions and the caregivers who provide the frontline services needed to maximize the chances of survival and return to normalcy for patients who are infected and develop clinical symptoms. In this challenging time, it will be necessary to deploy surgeons to work outside of their usual specialty to maximize the effectiveness of available clinicians.

Early resources that will be valuable at the time of entry into the intensive care unit care activities include these Society of Critical Care teaching modules for noncritical care clinicians and disaster response recommendations.