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

Clinical Issues and Guidance

Promising Therapeutics

Update on Hydroxychloroquine

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

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.

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

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

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?

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

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

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

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

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.