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Clinical Issues and Guidance

Treatment for Disordered Coagulation in COVID-19 Patients

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

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

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

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

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.