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

Clinical Updates

Promising Therapeutics: Convalescent Plasma and Early Vaccine Data

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

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

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

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

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

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.