Patients with ST Segment Elevation Myocardial Infarction ...

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Critical Pathways in Cardiology Journal Publish Ahead of Print

DOI: 10.1097/HPC.0000000000000223

Clinical Pathway for Management of Suspected or Positive Novel Coronavirus-19

Patients with ST Segment Elevation Myocardial Infarction

Lauren S. Ranard, MD,* Yousif Ahmad, MD,* Amirali Masoumi, MD,* Taylor Chuich,

PharmD,* Marie-Laure S. Romney, MD, MBA,† Nicholas Gavin, MD, MBA, MS,† Osman R.

Sayan, MD,† Ajay J. Kirtane, MD, SM* LeRoy E Rabbani, MD*

Affiliations:

*Department of Medicine, Division of Cardiology, NewYork-Presbyterian/Columbia University

Irving Medical Center, New York, NY

†Department of Emergency Medicine, NewYork-Presbyterian/Columbia University Irving

Medical Center, New York, NY

Corresponding Author: LeRoy E. Rabbani, MD, Department of Medicine, Division of

Cardiology, NewYork-Presbyterian/Columbia University Irving Medical Center, 173 Fort

Washington Avenue, New York, NY 10032. Telephone Number: (646) 522-7428. E-mail:

[email protected]

Conflicts of Interest and Source of Funding:

Dr. Kirtane reports institutional funding to Columbia University and/or Cardiovascular Research

Foundation from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, Philips, ReCor

Medical. Personal: CME/conference honoraria and travel/meals only. For the remaining authors

none were declared.

Copyright © 2020 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.

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ABSTRACT

Novel coronavirus 19 disease (COVID-19) is an escalating, highly infectious global pandemic

that is quickly overwhelming healthcare systems. This has implications on standard cardiac care

for ST elevation myocardial infarctions (STEMI). In the setting of anticipated resource scarcity

in the future, we are forced to reconsider fibrinolytic therapy in our management algorithms. We

encourage clinicians to maintain a high level of suspicion for STEMI mimics, such as

myopericarditis which is a known, not infrequent, complication of COVID-19 disease. Herein,

we present a pathway developed by a multidisciplinary panel of stakeholders at NewYork-

Presbyterian/Columbia University Irving Medical Center for management of STEMI in

suspected or confirmed COVID-19 patients.

Key words: acute coronary syndromes, fibrinolysis, coronavirus, STEMI, disaster management


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INTRODUCTION

Novel coronavirus-19 disease (COVID-19) is a global health threat caused by SARS-

CoV-2 that has rapidly spread throughout the world, now affecting 196 countries/regions.1 Given

the highly contagious nature of this disease, there are implications on standard practice for

cardiac care and challenges that healthcare systems will need to address.

In regions where COVID-19 is highly prevalent, institutions have taken measures to

preserve resources, including personal protective equipment (PPE), and avoid staff exposure.

This required suspension of elective cardiac catheterization procedures, outpatient office visits

and adjustment of clinical in-patient services. However, the systems of care for ST elevation

myocardial infarction (STEMI) patients also need to be addressed. In the United States, primary

percutaneous coronary intervention (PCI) is the standard of care.2-6

Unfortunately, in this

precarious and unsettling time, with transmission dynamics of the virus not fully understood and

limited PPE and resources, the balance of staff exposure and patient benefit requires

reconsideration. Fibrinolysis in this setting is controversial. As this pandemic evolves, a number

of institutions throughout Asia have been forced to incorporate fibrinolytics into their STEMI

care plans.7

The NewYork Presbyterian/Columbia University Irving Medical Center (NYP-CU)

developed an institutional pathway for management of suspected or confirmed COVID-19

patients who have evidence of STEMI. This algorithm has been developed by a multidisciplinary

group of key stakeholders, including cardiology, emergency medicine and nursing. It merits

emphasis that this healthcare crisis is a dynamic situation and little is known about the impact of

public health emergencies on STEMI systems of care.


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SCOPE

This institutional pathway has been created to guide the response to person under

investigation (PUI) or confirmed COVID-19 patients. Prior to widespread community

transmission of disease, a PUI was defined by the presence of any of the following

characteristics: fever, respiratory symptoms (cough, shortness of breath, sore throat), travel

within the past 14 days to a location with an associated travel alert notice or exposure to a

confirmed case or cluster of COVID-19 disease. However, the New York City area has become

the epicenter of the United States outbreak. Due to this, all patients presenting to the hospital are

considered a PUI for COVID-19 disease.8

ST-ELEVATION MYOCARDIAL INFARCTION

Definition

A STEMI is defined by the presence of chest pain or suspected anginal equivalent and new

ST elevation at the J-point in two contiguous leads with a cutoff point of ≥ 1 mm in all leads

except leads V2–V3, which have the following cutoff points:

• ≥2 mm in men ≥40 years,

• ≥2.5 mm in men <40 years, or

• ≥1.5 mm in women regardless of age.

In the absence of ST elevation, new left bundle branch block (LBBB) with ongoing chest

pain is considered to be a STEMI equivalent.


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INITIAL ASSESSMENT

Vital Signs

Prior to checking vital signs, a surgical mask should be donned on the patient.

Additionally, personnel evaluating should be in full personal protective equipment (PPE)

including surgical cap, eye protection, gloves, gown and surgical mask.9 Vital signs should

include: temperature, pulse, respiratory rate, blood pressure and oxygen saturation.

Twelve-Lead Electrocardiogram

An electrocardiogram (EKG) should be obtained on arrival and interpreted within 10

minutes.

Careful consideration of the EKG is of vital importance as myopericarditis and

pericarditis can be seen in COVID-19 patients. Inflammation associated with myopericarditis

(especially the focal form) can produce chest pain and EKG changes that are clinically

indistinguishable.10

There have been several reports of STEMI in this population with

subsequent angiography showing no coronary artery disease.11, 12

The following EKG factors

may favor inflammation rather than coronary obstruction:

• ST segment elevation in multiple coronary artery distributions (especially in patients that

are clinically stable)13

• PR depression in leads with ST segment elevation14

• Absence of reciprocal ST segment depression or changes (with the exception of leads

aVR and lead I)15

Outside of myopericarditis and pericarditis, ST segment elevation can also occur from a

wide range of clinical conditions including takotsubo cardiomyopathy, left ventricular

hypertrophy, left ventricular aneurysm, sarcoidosis, acute aortic dissection, pulmonary


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embolism, hyperkalemia, acute cerebral hemorrhage and post electrical cardioversion.16

History and Physical

Due to the high prevalence of COVID-19 disease in the community, all patients have a

high pre-test probability of infection. Anecdotally, the pre-test probability of COVID in STEMI

patients seen in Lombardy, Italy is 50%.

Patient risk stratification remains of utmost importance. Factors that increase the

probability of acute plaque rupture events include age (men > 45, women > 55), dyslipidemia,

hypertension, diabetes mellitus, family history of coronary artery disease and smoking history

should be taken into account. Additionally, given possible mimics of STEMI in the COVID-19

population, limited bedside echocardiography or point of care ultrasound should be performed as

an adjunct to EKG to assess for LV function, wall motion and pericardial effusion. A careful

clinical history and evaluation should be performed to assess for symptoms of acute coronary

syndrome. A focal wall motion abnormality on bedside echocardiography in the distribution of

ST elevation raises suspicion for an acute coronary occlusion.

Cardiac Monitor

IV Access (16-20 Gauge) x 2

Laboratory Work

• Basic labs: Complete blood count with differential, Basic metabolic panel/Magnesium,

Hepatic function panel, Prothrombin time, INR, aPTT

• Cardiac specific labs: Institution specific protocol for troponin assay, NT-pro-BNP, CK,

CK-MB


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• Infectious disease: Respiratory viral panel, SARS-CoV-2, Blood cultures x 2, Sputum

culture, MRSA PCR, Urinalysis, C-reactive protein, Erythrocyte sedimentation rate,

Procalcitonin, IL-6 level, Lactate dehydrogenase, Ferritin, D-dimer

• As appropriate: Urine/serum HCG (if female), Toxicology/drug screen

INITIAL MANAGEMENT

In the United States, rapid testing for COVID-19 is not available; therefore, it is

impossible in the emergent setting to determine if a patient is infected when making the decision

regarding emergent PCI. Additionally, in New York City, where there is a high degree of

community spread, there is increased concern that a patient could be asymptomatic but spreading

disease. The lack of rapid testing is a major challenge given the urgency of STEMI care.

It is well established that primary PCI is the gold standard for STEMI care, with a ~7%

reduction in overall short-term death compared to fibrinolysis.3 However, activation of the

cardiac catheterization lab (CCL) during a pandemic potentially strains healthcare resources and

puts multiple healthcare workers at risk for exposure. Therefore, fibrinolysis, though

controversial, can be considered. The decision to activate the CCL should be made after a risk

and benefit discussion with the interventional cardiology attending and determined on a case-by-

case basis. Factors that should be considered include: presumed location of infarct (anterior

infarcts are associated with higher cardiac mortality),17

bleeding risk, and level of suspicion for

myocarditis. Advanced age, female gender, HTN, kidney failure and clopidogrel treatment prior

to admission are predictors of in-hospital major bleeding after fibrinolytic therapy.18

Lastly,

fibrinolytic therapy should not be considered in patients where there is medium to high suspicion

for myocarditis as there is a risk of accumulation of fluid around the pericardium and tamponade.


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If the decision is made to bring the patient for emergent angiography +/- primary PCI,

please see clinical pathways for STEMI care previously published.19

If suspicion for acute

coronary occlusion remains high after initial assessment, and the risk of bringing the patient to

the CCL (either locally or for transfer from a hospital without on-site catheterization laboratory

facilities) is prohibitive, then fibrinolysis can be considered (Figure 1). If ACS symptom onset is

< 12 hours from time of presentation and there are no contraindications to fibrinolysis (Table 1),

patient is a candidate for tenecteplase therapy. The following adjunctive medical therapies in

addition to tenecteplase are recommended (Table 2):

Aspirin

Nonenteric-coated chewable tablet(s), 325 mg or 324 mg (4, 81mg tablets), should be

administered, followed by 81mg oral daily starting on the subsequent day.

Unfractionated Heparin

A bolus of heparin (60 units/kg, maximum 4000 units) should be administered. A

continuous drip can then be started at 12 units/kg/hr (maximum initiation rate 1000 units/hr). A

aPTT should be obtained 6 hours after initiation of drip. Heparin dose adjustments should be

made per the NYP heparin protocol to achieve an aPTT of 50-70 seconds (1.5 - 2.0 times

control). The duration of the heparin drip should be for a minimum of 24 hours, however, can be

extended to 48 hours depending on the clinical course and bleeding risk of the patient.

P2Y12 Antagonist

This should be administered as early as possible, unless there are contraindications.

Ticagrelor (Brilinta®

) or Clopidogrel (Plavix®

) are the two options for adjunct therapy and have

equivalent efficacy in STEMI patients treated with fibrinolysis.20

Ticagrelor as an adjunct


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therapy with fibrinolysis has only been studied in patients aged less than 75 years, therefore will

only be administered in this setting.20

Ticagrelor – 180mg loading dose (regardless of past P2Y12 therapy), followed by 90mg every

12 hours starting 12 hours after the initial loading dose. The FDA has approved the use of

crushed ticagrelor to be administered in water by swallowing or via nasogastric tube.

Contraindications and precautionary use include: history of intracranial hemorrhage, second

degree or greater heart block or concomitant medical therapy that interferes with metabolism

(oral or IV therapy with reverse transcriptase inhibitors, strong CYP3A inhibitors [e.g.,

ketoconazole, clarithromycin], CYP3A substrates [e.g., cyclosporine, quinidine], strong

CYP3A inducers [e.g., rifampin, phenytoin]).

Clopidogrel – If ≤ 75 years, then 300mg loading followed by 75mg daily starting on the

subsequent day. If patient is > 75 years old, then a 75mg loading dose should be administered

followed by 75mg daily starting the subsequent day.

Treatment of COVID-19 with experimental therapy may alter drug metabolism. The VerifyNow

assay to monitor P2Y12 levels in patients who receive Remdesivir, Tocilizumab, and Sarilumab

should be considered. No dosing recommendations have been established when medications are

used concomitantly with P2Y12 inhibitors.

Tenecteplase

Tenecteplase was chosen as the fibrinolytic of choice due to ease of administration and

rapidity of onset. Please see dosing recommendations for Tenecteplase in Table 3. The dose of

Tenecteplase should not exceed 50mg and administration should be as a single bolus over 5

seconds. If fibrinolysis is administered at a location without CCL facilities, then the patient

should be transferred to a PCI capable center. Half of the NYP institutions are without an on-site


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CCL [NYP Allen Hospital; NYP Lawrence; NYP Lower Manhattan; NYP Hudson Valley

Hospital].

SUBSEQUENT MANAGEMENT

EKG

An EKG should be done 60-90 minutes and 4 hours post tenecteplase administration. The

first EKG following fibrinolytic therapy is used to assess for recanalization; it is considered

successful if there is a > 50% reduction is ST segment elevation. If there is < 50% reduction in

ST segment elevation, a risk and benefit discussion of rescue PCI should be pursued. If PCI is

pursued, this should be performed only to the culprit vessel.

Laboratory Monitoring

The following labs should be obtained 6 and 12 hours post-fibrinolytic therapy: complete

blood count, aPTT, PT, and fibrinogen.

Clinical Course

The patient should be monitored closely on telemetry for the duration of the

hospitalization. A formal transthoracic echocardiogram should be obtained. Although guidelines

recommend that angiography should ideally be performed within 24 hours of fibrinolytic

administration,2 cardiac catheterization for COVID 19 positive patients will be pursued during

hospitalization only in specific circumstances. If the patient has ventricular dysrhythmias,

recurrent acute coronary syndrome (ACS) symptoms, an anterior infarct, or poor left ventricular

function (EF < 35%), then angiography will be pursued. If none of these are present, cardiac

catheterization can be deferred until after recovery from COVID-19 illness. Prior to outpatient

cardiac catheterization, two consecutively negative PCR tests for SARS-CoV-2 should be

completed.


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INFECTION CONTROL

All personnel should be well versed in proper donning and doffing techniques for PPE as

directed by the CDC and institutional protocols. If the patient requires intervention in the CCL, a

minimal number of people should scrub into cases to limit personnel exposure and preserve PPE.

There should be a lower threshold for intubation prior to arrival in the CCL as those already

intubated have a lower risk of transmission to staff. This requires close communication with

critical care and anesthesia teams, and needs to be counterbalanced against the risk of exposure

to the emergency department and/or anesthesia teams. The patient should wear a surgical mask at

all times if not intubated. The patient should be directly transferred to/from the CCL to their

room with staff wearing full PPE, especially given the risk of arrest/cardiopulmonary

resuscitation/intubation or even vomiting during STEMI cases. There should be no interim

‘holding’ of the patient in the pre/post-procedural areas.

There are limited but illustrative data from previous coronavirus epidemics, notably

MERS and SARS, on CCL infection control measures and preparedness.21

Most CCLs do not

have negative pressure ventilation systems; therefore they are not designed for infection isolation

and require terminal cleaning after use. A recent study from Singapore highlights the high degree

of environmental contamination caused by SARS-CoV-2 virus; 13 of 15 sites in a COVID-19

patients room were positive prior to cleaning.22

All COVID-19 patients should be restricted to

one laboratory if possible. For further recommendations for the care and management of

COVID-19 patients in the CCL, please see considerations released by The American College of

Cardiology (ACC) and Society of Cardiovascular Angiography and Intervention (SCAI)

members.23, 24


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RESPONSE FROM OTHER REGIONS

A handful of Chinese and European institutions have developed care pathways to address

the situation of suspected or positive COVID-19 patients with STEMI. One published protocol

from Sichuan Provincial People’s Hospital in China relies on rapid nucleic acid testing. Once

rapid testing results and COVID-19 is excluded, then primary PCI is pursued if symptom onset

time is < 12 hours. If COVID-19 is suspected or confirmed, patient is stable and onset time

symptom onset is < 12 hours, then fibrinolysis is performed.7 Rapid nucleic acid testing is not

currently available at our institution, and the current PCR testing for SARS-CoV-2 takes 8-24

hours to result. Despite rapid nucleic acid testing being faster than our current PCR testing, it still

delays reperfusion time. Multiple companies and laboratories are working on developing rapid

testing, so it will likely become available in the future and then incorporated into our protocols.

European centers have had a varied response. Imperial College Healthcare NHS Trust

have published their protocol on social media, with adjustments to the protocol made following

discussion amongst various colleagues. There is an emphasis on not performing invasive

coronary angiography on patients who are critically ill with COVID-19 disease due to the poor

prognosis in such cases. Computed tomography of the chest after PCI (if performed) to assess

coronary arteries and LV function has been incorporated into their algorithm. Fibrinolysis is only

to be performed after discussion between two senior cardiologists.25

The National Health Service

England’s updated guidelines similarly advocate for consideration of fibrinolysis on a case-by-

case basis.26

From direct discussions with centers in Madrid, Barcelona and Amsterdam, all are

currently still offering primary PCI as standard of care for STEMI cases during the COVID-19

crisis.


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IMPACT ON SYSTEMS OF CARE

Patient reluctance to access the healthcare system during an infectious disease outbreak

as well as infection control measures can potentially lead to delays in management of cardiac

patients. A report from Hong Kong examined STEMI patents who underwent PCI during the

time-period that emergency infection protocols for COVID-19 were implemented. A large delay

in seeking care was seen during the outbreak period – the median time from symptom onset to

first medical contact time was 318 minutes (IQR 75-458) compared to 82.5 minutes (IQR 32.5-

195) during the same time-period in the previous year.27

Interestingly, anecdotal reports from

China report a reduction in STEMI volume by approximately 50% during the height of the

coronavirus outbreak.

Systems of care may also need modification to prevent patients from nosocomial

acquisition of disease. Nosocomial transmission was responsible for a significant number of

cases in previous coronavirus outbreaks, highlighting the need for strict infection control

protocols and procedures for both staff and patients.28, 29

The STEMI network in Lombardy,

Italy, reorganized their protocol to allow their ambulances to deliver STEMI patients to specific

hospitals that have a low number of COVID-19 patients.30

This may need to be addressed on a

national level to help protect our patients.

CONCLUSIONS

Beyond treatment and infection prevention measures, emergence and outbreaks of

infectious conditions affect systems of care. This requires development of interdisciplinary

strategies to adapt to the demands of a global pandemic and maximize acute care resources and

limit nosocomial spread of infection.


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Figure Legends

Figure 1. Clinical Pathway for Suspected or Confirmed COVID-19 ST Elevation Myocardial

Infarction Patients


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Figure 1.

CCU = cardiac intensive care unit; ECG = electrocardiogram; LV = left ventricular; PCI =

percutaneous coronary intervention; PUI = person under investigation.


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Table 1. Contraindications to Fibrinolysis

Absolute Contraindications Relative Contraindications

• Active internal bleeding or bleeding

diathesis

• Recent Ischemic CVA ( < 3 months)

• Intracranial neoplasm of cerebral vascular

lesion

• Suspected aortic dissection

• Recent Intracranial or intraspinal surgery

(within 2 months)

• Severe, uncontrolled HTN unresponsive

to emergency therapy

• History of hemorrhagic stroke

• Recent closed head/facial trauma (within

3 months)

• Pregnancy

• Chronic poorly controlled HTN or

SBP> 180 mmHg or DBP > 110 mmHg

on presentation

• CPR > 10 minutes

• Cerebrovascular disease

• Dementia

• Recent (2-4 weeks) internal bleeding

• Non-compressible vascular punctures

• Pregnancy

• Current use of anticoagulant (warfarin)

with INR > 1.7 or PT > 15 seconds

• NOAC use within past 24 hours

• Recent major surgery (i.e. CABG)

CPR = cardiopulmonary resuscitation; CVA = cerebrovascular accident; DBP = diastolic

blood pressure; HTN = hypertension; NOAC = non- vitamin K antagonist oral anticoagulant;

SBP = systolic blood pressure.


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Table 2. Adjunctive Medical Therapies to be Administered with Fibrinolysis

Medication Dosage

Unfractionated Heparin (IV) Administer 60 units/kg bolus (maximum 4000

units) followed by a drip at 12 units/kg/hr

(maximum 1000 units/hr); the goal aPTT is

50-70. The duration of therapy should be 24-

48 hours.

Aspirin 325mg oral or rectal, followed by 81mg daily

starting on the subsequent day.

Clopidogrel

OR

Ticagrelor*

If the patient is ≤ 75 years, administer 300 mg

oral loading dose, followed by 75mg daily

starting on the subsequent day. If > 75 years,

administer 75mg loading dose, followed by

75 mg daily starting on the subsequent day.

180mg oral loading dose, followed by 90mg

every 12 hours starting 12 hours after loading

dose.

*Ticagrelor is only recommended if the patient is less than 75 years of age.


ACCEPTED

23

Table 3. Tenecteplase Dosing

Patient weight (kg) Dose (mg)

< 60 30

≥ 60 to < 70 35

≥70 to < 80 40

≥80 to < 90 45

≥90 50

Note: Tenecteplase dose should not exceed 50mg


ACCEPTED

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