PATIENT SAFETY WORK PRODUCT: CONFIDENTIAL AND PRIVILEGEDINFORMATION CREATED AS PART OF LPSES – LEE HEALTH SYSTEM’S PATIENT SAFETY EVALUATION SYSTEM

COVID-19 Meeting # 8Medical Staff Updates and Discussion

May 13, 2020

“Failing to prepare is preparing to fail”

Benjamin Franklin

Lee Health Continuing Medical Education

Thank you for participating in the COVID Guidelines Update

• To receive CME credits for todays event:- Go to www.eeds.com- Enter code: 68jarl

• All attendees will be muted on entry

• Questions to the speaker:

-Use the chat option in WebEx

Guiding Premise

“The one thing we know- We have no idea what the ideal management of these patients really is.”

We will continue to learn, modify and adapt our guidelines as more information and literature becomes known.

AGENDA

COVID-19 Anticoagulation Case

COVID-19 Update in Children

COVID-19 Cardiology Update

COVID-19 OB Update

COVID-19 Serology Testing Update

Covid -19Anticoagulation Case

Dr. S Pammi

Case summary

4/21/2020 2123

Patient presents to GCMC with complaints:

56 y.o. female

6 day onset of fever, sore throat, diarrhea, dry cough, achy bones, appetite loss

She has a history of smoking and asthma but denies wheezing, cough or sputum production.

Denies any exposure to known Covid-19 case

Completed a Zpack from primary care provider.

No travel exposure

Case summary

PMH: asthma, CAD – h/o PCI, borderline diabetes, syndrome x, GERD, migraine headaches, anxiety and sleep apnea

Relevant surgeries: PCI-11/2019, carpel tunnel release, GI endoscopies, endometrial ablation, tubal ligation, bladder repair, hysterectomy, sinus surgery and hemorrhoidectomy

Family History: CAD, DM and Hyperlipidemia

Social History: active smoker 1pps x 18 years

Case Summary

MEDICATIONS:

• BRILINTA 90 MG tablet,

• (CHOLECALCIFEROL) 125 MCG (5000 UT) Cap,

• TRULICITY 0.75 MG/0.5ML subcutaneous injection, (ZETIA) 10 MG , (CRESTOR) 10 MG tablet,

• (XANAX) 0.25 MG tablet , (COQ-10) 50 MG Cap, aspirin 81 MG chewable tablet, Biotin 10000 MCG Tab,

• (ASCORBIC ACID) 500 MG tablet,

• (PROTONIX) 40 MG enteric coated tablet,

• (SINGULAIR) 10 MG tablet (controller)

• (TOPICORT) 0.25 % ointment

• (ZITHMAX) 250 MG tablet

• (NITROSTAT) 0.4 MG sublingual tablet

• (SYMBICORT) 160-4.5 MCG/PUFF oral inhaler (controller)

• (PROVENTIL,VENTOLIN) (2.5 MG/3ML) 0.083% nebulizer solution (reliever)

• (ZOFRAN ODT) 4 MG disintegrating tablet

• (ZYRTEC) 10 MG tablet

Case summary- initial ER

BP:106/59

Pulse: (!) 117 92 94

Resp: 18 16 16

Temp: (!) 102.7 °F (39.3 °C)(!) 101.3 °F (38.5 °C)(!) 102.2 °F (39 °C)100.8 °F (38.2 °C)

SpO2: 97% 97% 97%

Body mass index is 38.41 kg/m².

Exam: Normal

Labs:

SARS CoV-2 PCR: negative

CXR:NO acute cardiopulmonary disease

Disposition: Patient discharged home

Case Summary- comes back to ER

Returns to ER on 4/24/2020

56-year-old female presents today with fever cough myalgia symptoms ongoing for the past 10 days was seen at GCMC diagnosed with a negative COVID, continues to have fever, cough shortness of breath, not actively dyspneic upon exertion no vomiting, no chest pain. Presents for evaluation

BP: 122/60 109/67 102/67

Pulse: 105 79 79

Resp: 16 24 19

Temp: 101.4 99.9

SpO2: 94% 99% 97%

Exam:

Unchanged

Nothing new pertinent found

Case Summary

• Labs:

• SARS COV-2 pcr positive

• CBC normal

• Mild AST elevation

• CXR: read as no acute cardiopulmonary abnormality

• Disposition: Patient was discharged home to monitor symptoms

Case summary- 3rd ER visit

Patient returns to ER for third time on 4/25/2020 17:29

56 y.o. female. Patient presented to the ED with complaint of shortness of breath and a fever. She has been having a fever for the past 10 days. She was seen at HealthPark yesterday and diagnosed with COVID-19. She stated she became more short of breath today. EMS reported her oxygen saturation at 85% on room air. She was placed on oxygen.

• Exam: SAT 84% on RA

• General: warm to touch

• Respiratory: in mild distress, tachypneic, bilateral crackles

• LABS:

• Elevated LFT

• CBC normal

• PT/PTT: normal

Case Summary

Case Summary

4/25: Patient admitted. Placed on HFNC. Started on Azithromycin

Ferritin 269, LD 438, D-dimer not done. Started on Lasix 20mg.

4/27: Pulmonary consult: Started on Zinc, Vit C and thiamine. Advised to initiate proning.

4/27:ID consult: Stop Azithromycin and Started on Hydroxychloroquine

4/27: Cardiology called due to chest pressure complaints. EKG and cardiac enzymes negative and recommend continue ASA and Brilinta. Echo normal in 2/20- no repeat.

4/28: Transferred to ICU due to impending respiratory failure secondary to rapidly progressive respiratory failure

Case Summary

4/29: Progressively goes up to Flow 40%, FiO2 100%. Lasix continued. Patient instructed on proning. D-dimer drawn: 2.37- patient started on IV Heparin

5/1: Wheezing noted and started on Prednisone

Case summary

Case Summary

4/28ICU

4/29Hep

4/30 5/1Pred

5/2 5/3 5/4 5/8Disch

5/11Home

D-dimer 2.37 3.79 3.91 3.35 1.84 0.84

Fib 794 843

LDH 438 482 493 412 324

P/F 87 59

FiO2m 100 100 100 100 100 100 70 4L 2L

Case Summary

D11

Patient discharged on 3L/min O2 via nasal cannula

Discharge with Eliquis at 2.5mg daily for 30 days

Steroids were tapered off.

Patient doing well on follow up.

Case Summary

Covid-19

• Angiotensin II binds to receptors and promotes vasoconstriction and inflammation

• Covid-19 Binds to ACE II receptor located on endothelial cells and inactivates ACE II

• ACE II converts angiotensin II to angiotensin 1,7

• Angiotensin 1,7 vasodilates and reduces inflammation

Covid-19

ACE II

VWF

Factor 8

Anticoagulation for COVID-19 Protocol

BMI ≥ 40 kg/m2 CRCL ≥30 ml/min- Lovenox 40mg SQ BID

CRCL 15-29 ml/min- Lovenox 40mg SQ QD CRCL <15 ml/min- UFH 7500 units SQ q8h

PATIENTS ON ANTICOAGULATION PRIOR TO ADMISSION: Patients coming in on AC should be continued on anticoagulation.

Patients on DOAC should continue for original indication as appropriate.

Patients who are on Coumadin may be considered to transition to LMWH if eligible and no contraindication.

OR

D-dimer > 2.5 mcg/ml consider group III dosing if patient has

other clinical indicators of clinical worsening secondary to Covid-19

disease.

Full Anticoagulation dosing

CRCL ≥ 30 ml/min

Lovenox 1mg/kg SQ BID

CRCL 15-29 ml/min Lovenox 1mg/kg SQ QD

Patient who have confirmed VTE disease or develop other

indication for full anticoagulation such as AF.

Consider in the

following categories:

Patient with clinical signs and symptoms of VTE but cannot get definitive confirmation, consider

group III dosing.

CRCL < 15 ml/min Standard dose heparin drip APTT protocol

or Consult to pharmacist for anti-Xa

heparin drip protocol

GROUP III: HIGH RISK GROUP II: INTERMEDIATE

Patients with D-dimer > 2.5 mcg/ml with clinical symptoms accounted to Covid-19

disease.

Group II: Intermediate Dose

CRCL ≥ 30 ml/min Lovenox 0.5mg/kg SQ BID

CRCL 15-29 ml/min Lovenox 0.5mg/kg SQ QD

OR

CRCL < 15 ml/min

Low dose heparin drip APTT protocol

or Consult to pharmacist for anti-Xa

heparin drip protocol

GROUP I: PROPHYLAXIS

Patient with a D-dimer < 2.5 mcg/ml and are not on previous

anticoagulation and have no other confirmed need for full dose

anticoagulation.

Group I: Prophylactic Dose

OR

BMI < 40 kg/m2 CRCL ≥30 ml/min- Lovenox 30mg SQ BID

CRCL 15-29 ml/min- Lovenox 30mg SQ QD CRCL <15 ml/min- UFH 5000 units SQ q8h

*Modified anticoagulation doses: Apixaban 2.5 mg PO BID or Rivaroxaban

10 mg PO QD

Coumadin options for all those people who cannot get the DOAC or renal

failure

If the study is negative recommend go home

on modified anticoagulation dose* for 30

days

If still cannot get study use clinical

judgement on anticoagulation regimen.

Subgroup A Confirmed PE or DVT

Follow ACCP guidelines

Subgroup B Placed on full anticoagulation due to elevated D-dimer with progressive symptoms. Go home on modified

anticoagulation dose* for 30 days or until ambulatory

Subgroup C Candidates for full anticoagulation for high

suspicion of VTE but could not get confirmed: consider confirmatory study if

possible prior to discharge

If the study is positive follow ACCP guidelines

GROUP III: HIGH RISK GROUP II: INTERMEDIATE

Recommend modified anticoagulation dose* for 30 days

or until ambulatory and no contraindications.

GROUP I: PROPHYLAXIS

Consider modified anticoagulation* if patient has risk factors for immobility

and no contraindications.

Outpatient Therapy Anticoagulation

There are no current recommendations for outpatient anticoagulation.

All recommendations are for inpatient and discharge from inpatient.

However, patients following up from in outpatient centers after hospitalization from Covid-19 disease- be aware for signs of thrombosis.

Currently no recommendations for follow up D-dimers after hospitalization.

Thank You

COVID 19 – An Update in ChildrenYanet Rios , MD, FAAP, FHM

Epidemiology

• Children of all ages can get COVID-19, although they appear to be affected less commonly than adults.

• In a systematic literature review (from January 1 through March 18, 2020), children accounted for 1 to 5 percent of diagnosed COVID-19 cases worldwide.

This Photo by Unknown Author is licensed under CC BY-SA

Epidemiology

Data as of April 2, 2020, among the 149,760 laboratory-confirmed cases reported to the United States Centers for Disease Control and Prevention (CDC):

• 1.7 percent were in children <18 years.

• 70 percent of these cases were from New York City, the rest of New York state, and New Jersey.

• 90 percent of cases were associated with household or community exposure, and 10 percent were associated with travel.

Incidence has been expanded to other states since this report was completed following a similar pattern.

Demographics in children

• Age distribution:

• <1 year – 15 percent

• 1 to 4 years – 11 percent

• 5 to 9 years – 15 percent

• 10 to 14 years – 27 percent

• 15 to 17 years – 32 percent

• Sex Distribution:

• Males: 57%

• Females: 43%

• COVID-19 cases among children* aged <18 years, among those with known hospitalization status (N = 745),† by age group and hospitalization status —United States, February 12–April 2, 2020

COVID-19 and Breastfeeding

• It is unknown whether the SARS-CoV-2 can be transmitted through breast milk because available data are limited to very small case series.

• There is general consensus that breastfeeding should be encouraged because of his many maternal and infant benefits. In the setting of maternal COVID-19 infection , the infant may receive passive antibody protection.

• However, droplet transmission could occur through close contact during feeding (breastfeeding or bottle feeding). Strategies to prevent transmission of SARS-CoV-2 during infant feeding are well delineated by the CDC .

Risk for severe COVID 19 disease

• Severe cases of COVID-19 have been reported in children, including fatal cases but most children appear to have asymptomatic , mild or moderate disease and recover within one or two weeks of onset.

• Infants less than a year and children with serious underlaying conditions appear to be at greater risk for severe disease.

• Most common underlying conditions are:

Chronic Pulmonary Disease, including moderate to severe asthma

Cardiovascular disease

Immunosuppression

Chronic Kidney Disease

Chronic liver Disease

Endocrine Diseases

Severe Obesity

Clinical Manifestations

• Fever and cough are the most common reported symptoms in children.

• In the case series from the United States, complete information about symptoms was available for 291 children; 56 percent had fever, 54 percent had cough, and 13 percent has shortness of breath; 73 percent of children had at least one of these symptoms .

• In young infants, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can cause fever without any other manifestations, including respiratory symptoms and signs.

• Other common symptoms in this case series included cough (49 percent) and pharyngeal erythema (46 percent).

• Less common symptoms included fatigue, rhinorrhea/nasal congestion, diarrhea, and vomiting.

This Photo by Unknown Author is licensed under CC BY

Clinical Manifestations

In a series of 2135 children from China that included 728 children with laboratory-confirmed COVID-19 disease:

• approximately 55 percent of all cases were mild or asymptomatic

• 40 percent of cases were moderate (eg, clinical or radiographic evidence of pneumonia without hypoxemia)

• 5 percent of cases were severe (eg, dyspnea, central cyanosis, hypoxemia)

• <1 percent were critical (eg, acute respiratory distress syndrome, respiratory failure, shock).

COVID and Kawasaki Disease / Toxic Shock Syndrome

• There have been few reports of children with COVID-19 and clinical features that are similar to those of toxic shock syndrome and atypical Kawasaki disease (eg, abdominal pain, gastrointestinal symptoms, myocarditis) and laboratory findings associated with increased inflammation (eg, elevated CRP, erythrocyte sedimentation rate, and ferritin)

Pediatric Multi-System Inflammatory Syndrome Temporally Associated with COVID-19

• The New York City Health Department announced 15 cases between April 29 and May 3.

• The New York State Department of Health expanded that to 64 cases statewide and issued an advisory on what is being called "Pediatric Multi-System Inflammatory Syndrome Temporally Associated with COVID-19."

• Two children are known to have died in New York with the syndrome, a 5-year-old boy and a 7-year-old boy.

• Italy, Spain and the U.K. have noted an uptick in Kawasaki-like disease among children coincident with the COVID-19 outbreaks there.

• British health authorities warned about a small rise in children with severe COVID-19 and features consistent with toxic shock syndrome and atypical Kawasaki disease. "Abdominal pain and gastrointestinal symptoms have been a common feature as has cardiac inflammation."

Laboratory Findings

• Laboratory findings in children with confirmed infection from Wuhan were variable.

• Approximately one-quarter had white blood cell count <5.5 x 109/L and 3.5 percent had lymphocyte count <1.2 x 109/L

• Procalcitonin was elevated (>46 pg/mL) in 64 percent and C-reactive protein (CRP) was elevated (>10 mg/L) in 20 percent.

Chest X rays

• Chest radiographs may be unremarkable or demonstrate bilateral consolidation.

Chest CTo In a series of 171 children with

confirmed SARS-CoV-2 infection, findings on chest computed tomography included :

• ground glass opacity in 33%,

• local patchy shadowing in 19%, bilateral patchy shadowing in 12%, -and interstitial abnormalities in 1%.

Approach to Diagnostic

Suggested priorities for SARS-CoV-2 (COVID-19) testing

•These testing priorities refer to testing with RT-PCR (or antigen testing, if available).

SARS-CoV-2: severe acute respiratory syndrome coronavirus 2; COVID-19: coronavirus disease 2019; CDC: United States Centers for Disease Control and Prevention; IDSA: Infectious Diseases Society of America; ICU: intensive care unit; RT-PCR: reverse transcription polymerase chain reaction.* The number of confirmed COVID-19 cases in the community should be considered.¶ As testing becomes more widely available, routine testing of hospitalized patients may be important for infection prevention and management at discharge.

P R I O R I T Y C D C G U I D A N C E [ 1 ] I D S A G U I D A N C E [ 2 ]

First/High priority

•Hospitalized patients with symptoms•Health care facility workers, workers in congregate living settings, and first responders with symptoms•Residents in long-term care facilities or other congregate living settings, including prisons and shelters, with symptoms

•Critically ill patients receiving ICU-level care with unexplained viral pneumonia or respiratory failure (regardless of travel or exposure history)•Any individual (including health care workers) with fever or features of a lower respiratory tract illness and close contact with patients with laboratory-confirmed COVID-19 within 14 days of symptom onset (including all residents of long-term care facilities with a confirmed case)•Individuals with fever or features of a lower respiratory tract illness who are also immunosuppressed (including patients with HIV), older, or have underlying chronic health conditions•Individuals with fever or features of a lower respiratory tract illness who are critical to the pandemic response, including health care workers, public health officials, and other essential leaders

Second/Priority

•Persons with symptoms of a possible infection with COVID-19, including: fever, cough, shortness of breath, chills, muscle pain, new loss of taste or smell, vomiting or diarrhea, and/or sore throat•Persons without symptoms who are prioritized by health departments or clinicians, for any reason, including but not limited to: public health monitoring, sentinel surveillance, or screening of other asymptomatic individuals according to state and local plans

•Non-ICU hospitalized patients and long-term care residents with unexplained fever and features of a lower respiratory tract illness*

¶

Third

•Outpatients who meet criteria for influenza testing (eg, symptoms such as fever, cough, and other suggestive respiratory symptoms plus comorbid conditions, such as diabetes mellitus, chronic obstructive pulmonary disease, congestive heart failure, age >50 years, immunocompromising conditions); testing of outpatient pregnant women and symptomatic children with similar risk factors is also included in this priority level*

Fourth•Community surveillance as directed by public health and/or infectious diseases authorities

Diagnostic Considerations

• Detection of other respiratory pathogens (eg, influenza, respiratory syncytial virus, Mycoplasma pneumoniae) in nasopharyngeal specimens does not exclude COVID-19.

• In one study published by JAMA (Rates of Co-infection Between SARS-CoV-2 and Other Respiratory Pathogens. AUKim D, Quinn J, Pinsky B, Shah NH, Brown I SOJAMA. 2020), 8 of 20 children positive for SARS-CoV-2 were also positive for other common respiratory pathogens

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Management

• Supportive care

• Antimicrobial therapies are experimental.

• Convalescent plasma – The effectiveness and safety of infusing plasma from individuals who have fully recovered from COVID-19 into patients with severe or life-threatening COVID-19 is being studied in patients >18 years of age, similar studies are being organized for infants and children.

Inpatient Management

Children with COVID-19 and severe or critical lower respiratory tract disease generally require hospital admission.

• Severe disease is defined by a new requirement for supplemental oxygen or increased requirement from baseline without new or increased need for ventilatory support (noninvasive or invasive) .

• Critical disease is defined by new or increased need for noninvasive or invasive mechanical ventilation, sepsis, multiorgan failure, or rapidly worsening clinical trajectory.

Supportive care is the mainstay of therapy for children with severe or critical COVID-19. Most children with severe disease will improve with supportive care.

• The Pediatric Infectious Diseases Society has endorsed multicenter initial guidance on the use of antiviral agents for children with COVID-19/ SARS-CoV-2 , suggesting Remdesivir as the preferred agent.

Outpatient Management

Children with documented or suspected COVID-19 and mild symptoms (eg, fever, cough, pharyngitis, other respiratory symptoms) generally should be managed at home unless they have a chronic condition that increases their risk of severe disease.

Management is focused on prevention of transmission to others, monitoring for clinical deterioration, and supportive care.

Caregivers of children who are managed at home should be counseled about symptoms of clinical deterioration, which may occur suddenly after approximately one week of symptoms and should prompt urgent re-evaluation.

Symptomatic care for COVID-19 in the outpatient setting is similar to that for other upper respiratory or gastrointestinal clinical syndromes.

Important considerations in children

CDC released new data that revels what so many of you have been experiencing across the country:

• Children aren’t going to the pediatrician, and as a result, far too many are missing important immunizations to protect them against diseases like measles, meningitis and whooping cough.

• This drop in vaccine rates also means that children are not receiving all the other important health care that usually occurs at well-child visits, including physical exams, developmental screenings, and other important care.

• These visits are important for children’s health, and the Academy is published new guidelines on May 8th to pediatricians to manage these visits during the pandemic.

Use of Cloth Masks

• The CDC recommends that individuals ≥2 years of age wear a cloth face covering when they are in public settings where social distancing may be difficult to achieve (eg, grocery stores, clinician offices).

• Cloth masks are not recommended for children <2 years of age because of concerns about suffocation.

Hand Sanitizer Safety

• Although washing hands with soap and water, when available is preferred for hand hygiene, alcohol–based hand sanitizer is safe for use in children when the sanitizer is used according to the information on the Drug Facts label; there is no cause for concern if children eat or lick their hands after the hand sanitizer has fully dried.

• However, because ingestion of even a small amount of liquid hand sanitizer can cause alcohol poisoning in children (including hypoglycemia), children younger than six years should be supervised when using alcohol-based hand sanitizers, and alcohol-based hand sanitizers should be kept out of the reach and sight of children.

This Photo by Unknown Author is licensed under CC BY-SA

Concerns regarding prolonged confinement in children

• Although prolonged home confinement may provide an opportunity to enhance parent-child relationships, it may adversely affect children's physical and mental health

• They may be less physically active, spend more time with electronic devices, and eat a poorer quality diet.

• Mental health stressors include fear of infection, boredom, and social isolation.

• Clinicians should consider the potential for violence and look for signs of parental stress, irritability, depression, and/or harsh responses to child behaviors during each clinical encounter .They should ask about parent stress levels, methods to manage stress, social supports, and substance use.

• Clinicians can offer coping strategies ,resources, and/or referrals to mental health providers to families who may benefit from these interventions.

This Photo by Unknown Author is licensed under CC BY-SA

Resources related to prevention of childcare violence during COVID -19 Pandemic

• -AAP tips for parents experiencing stress over COVID-19

• -Child Care Aware of America

• -Global Partnership to End Violence Against Children

• -The National Child Traumatic Stress Network

• •Resources for talking with children about COVID-19 are available from multiple professional groups and others, including:

• -The American Academy of Child and Adolescent Psychiatry

• -The AAP: Talking to children about COVID-19

• -Coronavirus: A book for children. Written by Elizabeth Jenner, Kate Wilson, and Nia Roberts. Illustrated by Axel Scheffler.

• -COVIBOOK for children younger than seven years

• -The United States Centers for Disease Control and Prevention

• -The National Association of School Psychologists

• -The United Nations Office for the Coordination of Humanitarian Affairs. Inter-Agency Standing Committee(a children's book for children approximately 6 to 11 years of age)

Thank You

COVID 19 – Cardiology UpdateVladimir Ilic, M.D.

• Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing

coronavirus disease 2019 (COVID-19) has reached pandemic levels;

• Patients with cardiovascular (CV) risk factors and established cardiovascular

disease (CVD) represent a vulnerable population when suffering from COVID-19;

• Presence of CVD is associated with increased mortality in COVID-19 infections;

• CVD risk factors and disease correlate with increasing age

• Patients with cardiac injury in the context of COVID-19 have an increased risk of

morbidity and mortality.

Preceding coronaviruses outbreaks such as severe acute respiratory syndrome (SARS) and

Middle East respiratory syndrome (MERS) were associated with a significant burden of CV

comorbidities and complications.

Common cardiac complications in SARS were hypotension, myocarditis, arrhythmias, and

sudden cardiac death (SCD).

Diagnostic workup during SARS infection revealed electrocardiographic changes, sub-clinical

left ventricular (LV) diastolic impairment and troponin elevation.

MERS was associated with myocarditis and HF.

Severe COVID-19 infection is associated with myocardial damage and cardiac arrhythmia;

Autopsies of patients with COVID-19 infection revealed infiltration of the myocardium by

interstitial mononuclear inflammatory cells. COVID-19 infections are associated with

increased cardiac biomarkers levels due to myocardial injury.

The myocardial injury and the increased levels of biomarkers are likely associated with

infection-induced myocarditis and ischemia.

Cardiovascular Manifestations and Clinical Course of COVID-19 Infection

In a study by Shi et al. in 416 patients of whom 57 died, cardiac injury was a common finding (19.7%).

In the patients who died, 10.6% had coronary artery disease (CAD), 4.1% had HF, and 5.3% had

cerebrovascular disease.

Moreover, in multivariable adjusted models, cardiac injury was significantly and independently

associated with mortality (hazard ratio [HR]: 4.26).

In a study by Guo et al., elevated troponin T levels due to cardiac injury was associated with significantly

higher mortality.

These patients were more likely to be men, to be older and to have more comorbidities such as

hypertension, coronary heart disease.

Severe COVID-19 infections are also potentially associated with cardiac arrhythmias at least in part due

to infection-related myocarditis.

The potential mechanisms underlying myocardial injury in those with COVID-19 infection

are not fully understood.

However, in keeping with other severe inflammatory and/or respiratory illnesses, direct

(‘non-coronary’) myocardial injury is most likely the cause. Myocarditis, septic shock,

tachycardia, severe respiratory failure, systemic hypoxemia, Takotsubo syndrome or T1MI

triggered by COVID-19, are alternative causes.

Direct myocardial involvement mediated via ACE2, cytokine storm, or hypoxia induced

excessive intracellular calcium leading to cardiac myocyte apoptosis have been suggested

as alternative mechanisms. As quantitative biomarkers of hemodynamic myocardial stress

and HF, intracardiac filling pressures and end-diastolic wall stress seem to be the

predominant triggers of the release of BNP/NT-proBNP.

Diagnosis of Cardiovascular Conditions in COVID-19 Patients

Chest PainChest pain and breathlessness is a frequent symptom in COVID-19 infection;

•Chronic and acute coronary syndrome presentations can be associated with respiratory symptoms.

The symptom of chest pain or tightness is common in patients with active COVID-19 infection. It is usually poorly localized and

may be associated with breathlessness due to the underlying pneumonia.

Associated profound hypoxemia together with tachycardia may result in chest pain and electrocardiographic changes suggestive

of myocardial ischemia. Where biomarkers are altered, Type 2 myocardial infarction (MI) may be suggested. Patients with ACS

do, however, experience the more typical symptoms related to ischemia.

The presence of a COVID-19 infection can make the differential diagnosis more difficult, as shortness of breath and respiratory

symptoms may be present and may precede or precipitate cardiac signs and symptoms.

DyspneaDyspnea (shortness of breath) is one of the typical symptoms in COVID-19. Of 1099 adult inpatients and outpatients in China,

18.7% presented with dyspnea. With increasing disease severity, the proportion of dyspnea significantly increases (31–55% in

hospitalized patients and up to 92% of patients admitted to ICUs).

CoughCough is present in 59.4–81.1% of patients with COVID-19, irrespective of disease severity. Unproductive (dry) cough is more

frequent, whereas sputum production is present in 23.0–33.7%.

Acute Respiratory Distress Syndrome

ARDS is characterized by bilateral opacifications on chest imaging (e.g. bilateral ground glass opacifications on CT)

and hypoxemia that cannot be explained by other causes. Among 1099 adult inpatients and outpatients in China,

ARDS occurred in 3.4%, but in hospitalized patients, the rates are significantly higher (19.6–41.8%). The median

time from disease onset to ARDS is 8–12.5 days. The risk of ARDS increases with older age (≥ 65 years old),

presence of comorbidities (hypertension, diabetes), neutrophilia, lymphocytopenia, elevated laboratory markers of

organ dysfunction (e.g. lactate dehydrogenase [LDH]), inflammation (C reactive protein) and D-dimer. Mortality of

patients treated for ARDS in COVID-19 is high (e.g. 52–53%).

Cardiogenic Shock

• In COVID-19 patients with impaired end-organ perfusion at risk of cardiogenic shock (CS) (e.g. large acute

myocardial infarction [AMI]), consider also sepsis as possible or mixed etiology;

• Myocarditis should be considered as precipitating cause of CS

Marked elevations in cardiac troponin T/I concentrations (e.g. > 5 times the ULN)

may indicate the presence of shock as part of COVID-19, severe respiratory

failure, tachycardia, systemic hypoxemia, myocarditis, Takotsubo syndrome or

T1MI triggered by COVID-19.

In the absence of symptoms or ECG changes suggestive of T1MI,

echocardiography should be considered in order to diagnose the underlying

cause. Patients with symptoms and ECG changes suggestive of T1MI should be

treated according to guidelines irrespective of COVID-19 status.

BNP/NT-proBNP as quantitative biomarkers of hemodynamic myocardial stress

and HF are frequently elevated among patients with severe inflammatory and/or

respiratory illnesses.

While experience in patients with COVID-19 is limited, very likely the experience

from other pneumonias can be extrapolated to COVID-19.

As quantitative markers of hemodynamic stress and HF, the concentrations of

BNP/NT-proBNP in a patient with COVID-19 should be seen as the combination

of the presence/extent of pre-existing cardiac disease AND/OR the acute

hemodynamic stress related to COVID-19.

At least to some extent, the release of BNP/NT-proBNP seems to be associated

with the extent of right ventricular hemodynamic stress.

Authors:

Stefanini GG, Montorfano M, Trabattoni D, et al.

Citation:

ST-Elevation Myocardial Infarction in Patients With COVID-19: Clinical and

Angiographic Outcomes. Circulation 2020;Apr 30:[Epub ahead of print].

Quick Takes

Symptoms of STEMI were the main reason for presentation, and abnormal

wall motion was seen on echo in the majority of patients.

Culprit lesion was identified in 60% of the STEMI patients, while the rest

had type 2 acute MI.

The impact of primary PCI on time to reperfusion and outcomes during the

pandemic remains to be determined.

We identified 18 patients with Covid-19 who had ST-segment elevation indicating potential acute

myocardial infarction.

The median age of the patients was 63 years, 83% were men, and 33% had chest pain around the time

of ST-segment elevation.

A total of 10 patients (56%) had ST-segment elevation at the time of presentation, and the other 8

patients had development of ST-segment elevation during hospitalization.

A total of 9 patients (50%) underwent coronary angiography; 6 of these patients (67%) had obstructive

disease, and 5 (56%) underwent percutaneous coronary intervention (1 after the administration of

fibrinolytic agents).

The 8 patients (44%) who received a clinical diagnosis of myocardial infarction had higher median peak

troponin and D-dimer levels than the 10 patients (56%) with noncoronary myocardial injury.

A total of 13 patients (72%) died in the hospital (4 patients with myocardial infarction and 9 with

noncoronary myocardial injury).

The first challenge is that "[cardiovascular] manifestations of COVID-19 are complex with patients

presenting with AMI, myocarditis simulating a ST-elevation MI presentation, stress cardiomyopathy,

non-ischemic cardiomyopathy, coronary spasm, or nonspecific myocardial injury." The second

challenge is that the prevalence of the COVID-19 disease in the U.S. population remains unknown and

there is the risk of asymptomatic spread.

With the challenges taken into consideration, the statement recommends "[informing] the public that we

can minimize exposure to the coronavirus so they can continue to call the Emergency Medical System

(EMS) for acute ischemic heart disease symptoms and therefore get the appropriate level of cardiac

care that their presentation warrants.“

The statement also recommends targeting the use of primary PCI or fibrinolysis (at referral or non-PCI

capable hospitals) in patients with STEMI, aiming to avoid reperfusion therapy for those with other

causes of ST-segment elevation on the electrocardiogram, and maximizing the safety of the health care

team through the appropriate masking of patients and the use of PPE.

ACC, SCAI, ACEP Release Consensus Statement on

Management of AMI Patients During COVID-19

Quick Takes

Hydroxychloroquine has been discussed broadly as a potential

treatment for COVID-19.

In a large, single-center, observational study of ~1,400 patients

hospitalized with COVID-19, use of hydroxychloroquine did not

reduce the risk of intubation or death.

Use of hydroxychloroquine for treatment of COVID-19 should

primarily be limited to clinical trial settings to appropriately

examine potential benefits and harms.

Conclusions

Among patients hospitalized in metropolitan New York with

COVID-19, treatment with hydroxychloroquine, azithromycin,

or both, compared with neither treatment, was not

significantly associated with differences in in-hospital

mortality.

However, the interpretation of these findings may be limited

by the observational design.

ORIGINAL ARTICLE

Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19

Quick Takes

Several retrospective cohort studies reports no association

between ACEI or ARB use and COVID-19 test positivity.

Overall, these data support various society guidelines to continue

current treatment of chronic disease conditions with either ACEIs

or ARBs during the COVID-19 pandemic.

The data for clinical outcomes and measures of COVID-19

severity taking ACEIs and ARBs must be interpreted with caution,

given multiple limitations.

Non-Invasive Imaging

• Do not perform routine cardiac imaging in patients with suspected or

confirmed COVID-19;

• Prevent contamination from patients to other patients, to imagers and imaging

equipment;

• Perform imaging studies in patients with suspected or confirmed COVID-19

only if the management is likely to be impacted by imaging results;

• Re-evaluate which imaging technique is best for your patients both in terms of

diagnostic yield and infectious risk for the environment;

• The imaging protocols should be kept as short as possible.

Similar to rationing decisions made in preparation for the initial surge of COVID-19 cases, progressive and thoughtful

reintroduction of cardiovascular services must be based on robust ethical analysis. Relevant values to be

operationalized include:

1. Maximizing benefits such that the most lives, or life years are saved so that procedures or tests that are likely to

benefit more people to a greater degree are prioritized over procedures that will benefit fewer people to a lesser

degree;

2. Fairness such that like cases are treated alike, taking into consideration baseline health inequities;

3. Proportionality such that the risk of further postponement is balanced against the risk of exacerbating COVID-19

spread; and

4. Consistency such that reintroduction is managed across populations and among individuals regardless of ethically

irrelevant factors such as ethnicity, perceived social worth or ability to pay. Finally the promotion of procedural

justice, with the use of an ethical framework, is essential to ensure all decisions reflect best available evidence with

transparent communication.

Ethical Considerations

Thank You

COVID 19 – OB UpdateCherrie Morris MD,MS FACOG

System Medical Director OB Services

89

NO!

Responses to the pandemic

A look at our numbers and cases

What we know in general (currently) about COVID-19 and pregnancy

Management and treatment

Latest pending publications

OB Experience Overview

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OB Responses to COVID-19

ACOG, AJOG, SMFMCDCLee Health

CCH HPMC

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Labor and Delivery Responses to COVID-19 Pandemic

Discontinue use of Nitrous Oxide for pain management

Discouraged use of O2 /non-rebreather mask for non reassuring FHT

2nd stage labor through delivery regarded as an AGP. OB providers, labor RN, baby RN, NICU team (if needed) and anesthesia provider wear N95

70 min rule

Most OB practices recommending OB patients at 36 -37 weeks isolate at home as to avoid exposure/ infection prior to delivery

Neonates born to COVID-19+/PUI moms, are PUIs

Issue of Mother/baby contact; “the determination of whether or not to separate a mother with known or suspected COVID-19 and her infant should be made on a case-by-case basis”

92

Labor and Delivery, Business as Usual

• N/A: “universally down"• Daily census is down (early discharges, unit closures)• Patients seen daily down (i.e. lactation).

Total Deliveries

2020 2019

March April March April

HPMC 443 459 462 456

CCH 84 83 121 106

TOTAL 527 542 583 562

OB ED/TRIAGE CHECKS

2020 2019

March April March April

HPMC 631 579 863 737

CCH 182 163 260 273

TOTAL 813 742 1123 1010

Covid-19 Patients

HealthPark 4

Cape Coral 0

Several PUIsNo Severe Disease

1 Moderate Disease (more on next slide)

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Patients 1 and 2:

• Known Covid-19 + prior to admission

• Symptoms resolved prior to admission

• Both term

• Delivered vaginally; 1 patient had pp Hemorrhage and transfusion

Patient 3:

• Delivered by c/s @ 34 weeks (OB indication)

• Readmitted 5 days later for control of HTN and fever

• Initial SARS-coV-2 negative, repeat test positive

• Symptomatic and discharged

Patient 4:

• Significant comorbidities; pregestational IDDM, HTN, CKD

• Delivered preterm for OB indications

• Interval admission and ER visits

• Visited her neonate in NICU 3 days prior to second re-admission

• Second re-admission for hypoglycemia and fever (19 days from delivery)

• Tests positive SARS-Cov-2, CXR with b/l patchy infiltrates

• Neonate tests positive the following day

• Discharged Home on antibiotics

Participating center for the AAP/SONPM National Perinatal COVID Registry

➢Dr. William Liu, Neonatologist is the PI

➢All COVID+ mothers who deliver within 14 days of birth or 72 hours after birth are tracked

94

COVID-19 and Pregnancy

Current data suggest that pregnancy does not increase the risk for acquiring COVID-19 and pregnancy does not worsen the clinical course of COVID-19 (?). ( AJOG, Coronavirus disease 2019 ( COVID-19) pandemic and pregnancy, March 2020)

• Reviewed 55 cases, compared to SARS and MERS, no mortality, less mechanical ventilation, less obstetrical complications except preterm birth

Vertical transmission from mother to fetus is unlikely (controversial)

SARS-CoV-2 has not be detected in cord blood, amniotic fluid and placenta along with vaginal secretions* (that was last week).

COVID-19 infected women with who develop pneumonia, especially if intubated have an increased risk of preterm delivery before 37 weeks’ gestation

COVID-19 infection should be part of the differential diagnosis of intrapartum and postpartum fever, particularly when accompanied by respiratory symptoms and reduced oxygenation

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COVID-19 and Pregnancy, cont.

Physiologic changes of pregnancy may effect illness:

Immunosuppression of pregnancy may affect the exacerbation of the inflammatory response

• A shift in TH type 1 and 2 lymphocytes contributes to infectious morbidity by increasing maternal susceptibility to intracellular pathogens like viruses

Maternal situation or status may worsen in the second week of infection

Pulmonary volumes are altered, steady decrease in:

• Functional residual capacity, end expiratory volumes and residual volumes secondary to diaphragmatic splinting of the growing uterus, hence reduced total lung capacity and inability to clear secretions effectively

Pregnant women who develop COVID-19 pneumonia have the same rate of ICU admissions as non pregnant women ( NY reports)

COVID-19 in pregnant patients can receive the same treatments as those who are not pregnant, apart from evaluation and management of the fetus.

Goal is stabilization of the mother.

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NIH Classification of Disease Severity

Classification Description

Asymptomatic or Pre-symptomatic Infection

Positive test for SARS-CoV-2 but no symptoms.

Mild Any signs and symptoms (eg, fever, cough, sore throat, malaise, headache, muscle pain) WITHOUT shortness of breath, dyspnea, or abnormal chest imaging

Moderate Evidence of lower respiratory disease by clinical assessment or imaging and a saturation of oxygen (SaO2) >93 percent on room air

Severe Respiratory frequency >30 breaths per minute, SaO2 ≤93 percent on room air, ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) <300, or lung infiltrates >50 percent.

Critical Respiratory failure, septic shock, and/or multiple organ dysfunction

• Gestational age along with fetal vulnerability and viability.

• First trimester or < 14 weeks: organogenesis and miscarriage

• Second trimester 14-28 weeks:

• Periviability or potentially viable: 22 0/7-22 6/7

• Viability: 23 0/7 or greater

• Third Trimester: 29- Term or 40 weeks

• Preterm < 37 weeks

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Medication and Other Exposures in Pregnancy

Risk benefit ratio.

Time, dose and duration of exposure.

Most medications are not teratogenic. What is teratogenic in animals, may not be in humans.

Difficult to blame congenital anomaly on medication. Baseline risk of anomaly is 2-4%. Reporting bias.

Long term effects on neonate not always studied.

CXR (2 views- Fetal radiation dose 0.0005-0.01 mGy). Radiological Society of North America: No deterministic effect to the fetus at doses < 100 mGy (10 rads) Fetal risk is low and not associated with an increased risk of fetal anomalies or pregnancy loss when dose is less than 20-30 mGy (2-5 rads).

Radiographic studies as indicated. Chest CT and CT pulmonary angiography are not contraindicated in pregnancy (Fetal radiation dose is 0.01 – 0.66 mGy).

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MILD COVID-19, not Requiring Admission for OB Reasons

Routine Evaluation of mom and fetus as dictated by gestational age

Treatment of symptoms, especially hyperthemia in the 1st trimester -Elevation of the maternal core temperature during organogenesis may be associated with an increased risk of congenital anomalies, especially neural tube defects, or miscarriage.

Admit patients with mild illness and other comorbidity such as hypertension, diabetes, severe obesity, severe asthma or cardiovascular disease.

Admission of Pregnant Patient with Moderate/Severe COVID-19 with or without OB Indication

Admit to appropriate unit. Appropriate consultations/Multispecialty team.

Consideration to maternal positioning.

Fetal Monitoring should be individualized by OB and MFM, based on gestational age and stability of mother

Anticoagulation (unfractionated heparin/LMWH).• Prophylactic dosing• Therapeutic dosing ( d-dimer is elevated in pregnancy)• Extended course post-postpartum ( 12 weeks)

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TREATMENTS/MEDICATIONS

Medications unique to pregnancy/ or treatment of pregnancy related indications:

Betamethasone for fetal lung maturity (use in critically ill patient).

Caution with IV magnesium (4-6 gm bolus and 2 grams per hour) for fetal neuroprotection and seizure prophylaxis secondary to possible respiratory depression in those already compromised.

Nifedipine drug of choice for tocolysis.

Antiviral Drug therapy: Who and when to treat? Moderate vs. Severe? Agents are being evaluated and use remains investigational.

• Hydroxychloroquine and chloroquine: reported to inhibit COVID-19 in vitro

• Crosses the placenta

• Many studies support its use and show safety

• Accumulation in fetuses of animal ocular tissue but not observed in humans.

• Adverse maternal effects with QT prolongation and V-tach

• Remdesivir: nucleotide analogue that has activity against COVID-19 in vitro

• Limited data in pregnancy

• Not readily available

• Compassionate care program

• Covid19 studies excluded pregnancy and breastfeeding women

• Other medications:

• Tocilizumab/Infliximab

• Lopinavir-ritonavir (used in the treatment of HIV in pregnancy)

• Crosses the placenta

• May increase risk of preterm delivery

• Ribavirin and Baricitinib but are known teratogens

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Timing of Delivery

Delivery usually not indicated.

Maternal immunity to fetus.

Minimize the risk of postnatal transmission to the neonate.

Consider delivery in pregnancies > 32-34 weeks gestation in patients with pneumonia but not intubated prior to worsening of pulmonary status.

COVID19 is not an indication for cesarean.

Generally, management of labor is not altered in women giving birth during the COVID-19 pandemic or in women with confirmed or suspected COVID-19.

101

American Journal of Obstetrics & Gynecology Accepted Manuscript www.ajog.orgcommunicating and corresponding author Kjersti M. Aagaard, MD PhD (Professor)

Baylor College of Medicine & Texas Children’s Hospital

Department of Obstetrics & Gynecology, Division of Maternal-Fetal Medicine Houston, TX 77030

aagaardt@bcm.edu

ABSTRACT Background. Despite 2.5 million infections and 169,000 deaths worldwide (current as of April

20, 2020), no maternal deaths and only a few pregnant women afflicted with severe respiratory morbidity had been reported to be related to COVID-19 disease. Given the disproportionate burden of severe and mortal respiratory disease previously documented among pregnant women following other related coronavirus outbreaks (SARS-CoV in 2003 and MERS-CoV) and influenza pandemics over the last century, the absence of reported maternal morbidity and mortality with COVID-19 disease is unexpected.

• Case series. 9 pregnant patients in the late 2nd/3rd trimesters• Severe COVID-19 • Outcomes compared to the patients familial/household cohorts• 7/9 died. 1 at time of publication remained critical, 1 recovered • Maternal outcomes in each and every instance more severe than

their family /household member (n=33)• Patients from 7 level III hospitals in Iran over 30 days (Feb-March)• 5/9 > 35y/o, but so were the 2 survivors • No comorbidities• 4/9 IUFD (1 set of twins)

102

Vertical Transmission?

Visualization of SARS-CoV-2 virus invading the human placenta using electron microscopy

Gabriela N. ALGARROBA, MD1, Patricia REKAWEK, MD

1, Sevan A. VAHANIAN, MD

1, Poonam KHULLAR, MD

2, Thomas PALAIA, MS

3, Morgan

R. PELTIER, PhD3, Martin R. CHAVEZ, MD

1, Anthony M. VINTZILEOS, 4 MD

1

ABSTRACT: We present a case of rapid clinical deterioration in a woman at 28 weeks’ gestation due to

severe COVID-19 infection. Using electron microscopy to evaluate for potential viral transmission in the

placenta, we visualized and identified coronavirus virions invading into syncytiotrophoblasts in placental

villi. To our knowledge, this is the first report demonstrating direct evidence of SARS-CoV-2 virus invasion

in placental tissue and placental infection associated with SARS-CoV-2 virus.

1 published report of

detection in amniotic fluid

Report out China of IgM

antibodies in a 2 hour old

neonate, vaginal

secretions negative

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A Summary of Where We Are (Today)

▪ Presentation with worsening symptoms (hypoxia) on day 2 of azithromycin with known COVID-19 infection

▪ Admit with sepsis pneumonia

▪ Deterioration after 10 hours

▪ Intubation

▪ Hypotensive, NE drip to aid in perfusing the placenta

▪ Antenatal steroids

▪ Therapeutic anticoagulation on heparin (severe COVID-19 and elevated d-dimer)

▪ Rescue dose of tocilizumab (waiting for Remdesivir approval)

▪ Mag Sulfate 4 gram bolus (fetal neuroprotection)

▪ C/S

▪ Remdesivir for 10 days

▪ Recovers

▪ Discharge on Enoxaparin for 12 weeks

▪ Infant negative on DOL 2 and 3

…tomorrow?

Thank You

COVID 19 – Serology Testing UpdateStephanie Stovall, MD

105…tomorrow?

Serology tests for SARS-CoV-2CDC

FDA

IDSAWHO

106

Lee Health SARS-CoV-2 serology test (ambulatory)

107

• https://www.cdc.gov/coronavirus/2019-ncov/lab/serology-testing.html

• https://www.who.int/news-room/commentaries/detail/immunity-passports-in-the-context-of-covid-19

• https://www.idsociety.org/globalassets/idsa/public-health/covid-19/idsa-covid-19-antibody-testing-primer.pdf

• https://www.fda.gov/news-events/fda-voices/insight-fdas-revised-policy-antibody-tests-prioritizing-access-and-accuracy

References

Thank You