EBOLA VIRUS DISEASE: Perspective of Both a Clinician and a Suspect Case

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EBOLA VIRUS DISEASE: Perspective of Both a Clinician and a Suspect Case

Lewis Rubinson MD, PhD

Director, Critical Care Resuscitation Unit

R Adams Cowley Shock Trauma Center

Associate Professor of Medicine

University of Maryland School of Medicine

RELEVANT DISCLAIMERS AND DISCLOSURESSite PI (Univ of MD) and Protocol Comm Co-Chair for a US DHHS FDA/BARDA contract for the United States Critical Illness and Injury Trials Group Program in Emergency Preparedness

Scientific Advisory Board member for GlaxoSmithKLine and Phillips/Respironics

Received honoraria and travel support from academic and public health professional societies.

Subcontractor to ICF international for an Ebola preparedness effort for the US DHHS Office of the Assistant Secretary for Preparedness and Response

World Health Organization consultant clinician in Sierra Leone. This talk has not been approved by the WHO and should not be considered to express any official policies or information releases. The details and opinions expressed are only my own.

EBOLA VIRUS HISTORY20+ documented outbreaks after 1st identified outbreak in 1976

Largest previous outbreak in Gulu, Uganda (2000) with 425 documented human cases

Public health and community-initiated measures controlled past outbreaks

Early case finding/ contact tracing, early isolation, case management (healthcare), and proper mgmt of dead bodies

EBOLA VIRUS DISEASE 2014 WEST AFRICA? Initial case in Guinea in Dec 2013

Mar 2014- outbreak rapidly takes hold in urban Guinea

WHAT WAS PROVEN ABOUT EVD CLINICAL CARE BEFORE 2014?Prior clinical guidance based on limited data and care in very challenging environments

Oral vs parenteral fluid resuscitation was opinion-based

Driven from cholera experience, but N/V and mental status issues may make different

Amount of fluid is controversial

Addl supportive care regimens were opinion-derived and controversial when compared to modern critical care knowledgebase

Nutrition (? Importance, timing, amount)

SUMMER PRE-DEPLOYMENT DUE DILIGENCEResponding to disasters for nearly 15 years (mostly US-based)

Security, accountability, logistics, medical pre-screening, vaccinations and malaria proph, life/disability insurance

Background in biosecurity

Had served on VHF WGs over past decade

Read everything I could about EVD and brushed up on trop med

Reached out to USG, WHO and other colleagues with boots on ground clinical knowledge and situational awareness to better ready myself

Self-directed crash course in Sierra Leone history, culture, politics, security situation and geography

Kenema Government Hospital

IN THE MEANTIME…

WHERE IS SIERRA LEONE?

SIERRA LEONE

SIERRA LEONEDecade long civil war ended in 2002

GDP ~ $4 billion (2012)

Approx 6 million people

> 40% 0-14 years old

Life expectancy < 50 y/o

~ 100 physicians for country prior to EVD

Worst maternal mortality in world (2000)

Literacy rate ~ 35%

Minerals are major resources (diamonds, bauxite, gold)

TRAVELING TO KENEMAFlights scheduled, cancelled and routes changedBaltimore to Phila, to Paris, to Nouakchott, Mauritania to Conakry, Guinea—UNHAS flight to Freetown, SL

Due to flight changes no visa for Guinea

In custody for several hours (language barrier) until Visa approved

Luggage did not arrive

At hotel, learned from email that MD I was to replace in Kenema has been med evac for EVD

UNHAS flight following day, no water taxis running to Freetown since no commercial aircraft

4 hr delay getting ground trans and 5+ hr drive to Freetown

STILL TRAVELING TO KENEMAPromed and email traffic chatter that pts are stacking up at referring facilities since US MD was evacuated Kenema

UN security briefing, WHO mission brief, skipped the bank

Still no luggage. Given a bottle of hand sanitizer from WHO communications lead

“You’re going to Kenema, you will need it more than me”

5 hr drive to Kenema

WEST AFRICA: BASELINECourtesy CDR James Lawler

MAJOR PILLARS OF EVD CONTROLContact tracing and case finding

Early isolation

Clinical care

Safe treatment of the dead

ARRIVAL AT KENEMA GOVERNMENT HOSPITAL~30 + HCW infections, nearly 20 died

No SL physicians working in ETU

Since Dr. Crozier illness and evac, no clinical oversight in ETU

Unknown census

Only dedicated Lassa ward in the world

ETU referral center for western/central SL

LEARNING FROM THE EXPERTSI was clinical lead for KGH but team effort to make KGH function.

WHO team responsible for elements of patient care when I arrived

Frederique Jacquerioz (trop med, Lassa expert, EVD experience in Guinea)

Suzanne Donovan (IC physician from LA, very thoughtful about PPE)

Dario Gramuglia (logisitician, EVD experience with MSF)

Rebecca Stretch (IC nurse, tons of EVD experience with month experience at KGH)

Henry Kyobe Bosa (Ugandan physician with significant EVD outbreak experience)

PLEASE SHOW ME HOW TO STAY SAFE!!

HOW IS AND WHEN IS EBOLA TRANSMITTED?EVD is transmitted from infectious body fluids entering your body (through mucus membranes or skin breaks)

Sicker people with more symptoms have production of larger volumes of body fluids (emesis, diarrhea) ---typically more infectious

Most of these people are too symptomatic to be out and about

Close contacts at home who are caring for these people or sharing bathrooms, etc

Healthcare workers…in US especially ICU workers (intensity of exposure and duration of exposure)

450 HCWs infected as of Oct 2014

Fomite transmission less likely but depends on ambient conditions

Airborne transmission unconfirmed but aerosolization with projectile vomiting, therapeutic interventions, flushing of toilet with large infectious burden of stool all plausible

Virus culture and reverse-transcription polymerase chain reaction (RT-PCR) results from 54 clinical samples collected from 26 patients with laboratory-confirmed Ebola hemorrhagic fever.Bausch D G et al. J Infect Dis. 2007;196:S142-S147

© 2007 by the Infectious Diseases Society of America

GERMANY DURING THIS OUTBREAK

Kreuels B et al.

N Engl J Med

2014

Risks of household transmission of Ebola hemorrhagic fever (EHF) among 173 household contacts of 27 EHF patients, after adjusting for direct physical contact during illness and contact with the patient's body fluids.Dowell S F et al. J Infect Dis. 1999;179:S87-S91

© 1999 by the Infectious Diseases Society of America

Virus culture and reverse-transcription polymerase chain reaction (RT-PCR) results from 33 environmental samples.Bausch D G et al. J Infect Dis. 2007;196:S142-S147

© 2007 by the Infectious Diseases Society of America

TRICKS OF THE TRADE

THE CLOCK STARTS…ITS ALREADY HOT

BUDDY CHECK

DISCIPLINED DOFFING

PPE FOR RESOURCE-RICH COUNTRIESWest African transmission/ prevention is more similar than different for resource-rich countries.

No simple PPE widget to buy and you are protected (takes discipline and detailed process to minimize self-contamination)

Transmission in resource rich may have better environmental controls but impact on care interventions and disease transmission remains largely uncertain

Airborne precautions are not unreasonable because interplay with modern therapeutics (oxygen delivery, etc) remains unknown

Best means to disinfect during PPE doffing remains uncertain

Spray disinfectant (bleach, hydrogen peroxide) vs wipes

ORGANIZATION OF AN ETUSuspect ward- Annex at KGHPts who are triaged as suspect

Ambulance pts

Mixture of EVD and non-EVD pts

Confirmed ward- Med/surg ward at KGH

“

best” place to provide care

Convalescent ward

Pts significantly improving w/o rebound sxs and awaiting neg PCR

HCW flow should always go from Suspect ward to either Confirmed or Convalescent ward

ETU is “high risk”, outside of ETU must be protected. No one in PPE, once in ETU can leave without doffing/ disinfection. Materials which cannot be disinfected stay in ETU

GOING INDr. Henry and I were “clinical buddies”Typically 2 hours in am and 2 hours in pm

Heat limitations for duration and times of day for ETU access

Unreliable electricity made night shifts too unsafe

We established consensus amongst us and nurses about goals for particular shift

We kept each other on track because could be distracted off target by so many needs in ETU

Final buddy check of PPE and hands go to apron (just like in OR when not actively involved in procedure)

We start in the suspect ward

KGH STAFF

THE ANNEX

SUSPECT WARDWe enter through the front gate and hop the trip hazard and pass the first few rooms to meet people outsideThere are clearly sick people with probable EVD in ward but we bypass them to try to talk to lower suspicion folks first

Do not want to give someone EVD because they were incorrectly triaged to ETU

Update the census and determine duration of sxs

PCR may be at detection threshold or below in early disease (need 72 hrs to r/o)

Census then matched to EVD PCR list (huge issue about pt id, sample matching integrity)

Goals of suspect ward

Get low-med suspect pts PCR so can be d/cd rapidly

Identify very high suspicion pts and make sure they have PCR so can move to confirmed unit for more aggressive treatment

Keep all pts separated but really try to separate high prob from all others

CENSUS EXAMPLE

PERSONS UNDER INVESIGATION (PUI) FOR EVDUS CDC, state and local public health have criteria for screening

All US healthcare entities which must be able to screen/ temporarily isolate and protect HCWs from EVD

Can’t control where possible persons with EVD present

Timely travel from impacted areas or occupational exposure to EVD are best 1

st

screening questions

Causes of fever and other symptoms are much more likely to be due to non-EVD etiologies

Even in West Africa, sick contact is best way to assess risk of EVD

SCREENINGScreening criteria must be translated to make clinically operational

Symptom duration is not part of criteria but useful (nausea/vomiting for weeks is not EVD)

Diagnostics for alternate diagnosis may not be available at your institution

MAKING THE EVD DXSamples require special handlinghttp://www.cdc.gov/vhf/ebola/hcp/interim-guidance-specimen-collection-submission-patients-suspected-infection-ebola.html

For most hospitals, ability to rapidly “rule out” will be paramount

Even with rapid dx PCR, may not be able to rule out in first 72 hrs

Towner JS et al

. J Virol

2004.

RESOURCE-RICH GENERAL ISOLATION STRATEGIESPt is cared for in dedicated space and not moved (except from ED depending on hosp plan)

Diagnostics- most labs are only using POC tests

CDC guidance suggests can use general labs but most hospitals will not be doing so

Limited labs (will vary by equipment and process solutions)

Bedside ultrasound mainstay of imaging

Some facilities are using portable diag Xray as well

No CT, MR, cath lab, etc for suspected or confirmed EVD at most hospitals

American College of Surgeons put out EVD guidance

Will require extensive training, planning and facilities commitment if any hospital chooses to operationalize

POSSIBLE ADVERSE CONSEQUENCES OF PUI PROCESSPerson travels recently from impacted countryHas neurological signs/sxs suggestive of acute CVA

Do you go immediately to CT scanner for possible TPA admin for CVA?

How do you decide what is best for pt?

How are facility and staff safety factored in?

If there is a time sensitive window, what process is in place to optimize outcomes when EVD PCR from LRN cannot be turned around in necessary window?

RAPID EVD ASSESSMENT TEAMMust be able to rapidly assess likelihood of EVD

Risk to pt if delayed dx or tx

Are there alternatives?

Risk to HCWs or facility for proposed eval/tx

CT scan vs procedure

Requires immediate activation of multi-disciplinary team

Public health, ID/inf control, clinicians, risk mgmt

Must have endorsement by hosp leadership to make decision or must make rapid rec and hospital leadership must make timely decision

Should be formalized and tested prior to need

ANNEX CONTINUEDNow we start assessing the pts who are high risk for EVD. Many are lying on the ground, prostrate. Some are near death. Most are in the same position as when they were brought in from the ambulances.

We provide water and Oral rehydration fluids (ORF) to those who everyone who can tolerate it as we assess them

We treat seriously ill with empiric ACT (for malaria), and ceftriaxone (or cipro) during severe GI dysfunction

We have approx 60-90 sec per pt and you learn how to assess pts in any position without breaching your PPE

We must move on as we still have the entire confirmed ward to see

ON TO THE CONFIRMED WARD15-20 pts are sitting outside of unit on open walkwayMany complain of myalgias, pruritus but generally “well-appearing”

We provide water, ORF, and paracetemol to each. We get their info, but we must move on

Inside ward, numerous pts at various stages of illness

Initial screen for severe illness---walking, eating, under blankets, signs of bleeding (gingival, epistaxis, peri-IV)

Ibrahima Bah E et al. N Engl J Med 2014 epub.

N Engl J Med 2014 1481-1495.

OTHER PREDICTORS OF POOR OUTCOME

N Engl J Med

2014 1481-1495.

AND STILL MORE PREDICTORS

Schieffelin JS et al.

N Engl J Med

2014 epub.

SURVIVORS

CONAKRY CLINICAL EXPERIENCE

Ibrahima Bah E et al.

N Engl J Med

2014 epub.

RUBINSON’S PRINCIPLES (= OPINIONS) FOR EVD CAREMinimization of numbers of people in pt’s room

Minimization of exposure

? Role of routine exam and assessments

Balancing pt needs with staff safety

There should be no emergencies

Procedures should be pre-briefed, choreographed and done by experienced, team-players

PACE

Novel therapeutics should be used in clinical trial if possible

Limited organ support reasonable but many interventions/ diagnostics will put staff, institution at high risk

A BIT OF A PERSONAL MISHAP1 day prior to finishing at KGH I stuck myself with an 18 G hollow bore needle through soiled glovesDeep stick

Determined by WHO and CDC to be high risk exposure and to be medically evacuated to NIH biocontainment center

Elected to enroll in rVSV vaccine PEP study

AN INTERESTING JOURNEYMost HCWs who become infected with EVD did not recognize exposureI simply had to wait for the future

Long drive back to Freetown and flight to US

EVD FEAR TAKES OVER USTold not to open door of airplane in AzoresConsidered dangerous and at time asymptomatic and only 48 hrs after exposure

Large police escort moving at very fast speed to get me to NIH

Had started to feel a bit ill at end of flight (anticipated timing for PEP sxs)

Symptomatic at NIH and Mr. Jordan ill in Dallas

FEELING NOT SO GREAT

Lai L et al.

JAMA

2015 epub.

GREAT CARE BUT VERY ISOLATING

FEAR AND POLITICS OVER SCIENCEDallas case and secondary caseExcessive public fear due to failed risk communication strategies

Became clear my sxs were due to PEP and I was all better

Length of stay at NIH longer than sxs warranted and then placed under what was essentially home arrest

Never would hurt anyone, but despite much more experience with EVD than any of the folks managing me, there was no place to appeal except in courts

Did not want to be identified to protect my daughter

PUBLIC HEALTH AND RESPONSE AGENCIES MUST BRING SENSIBILITY BACK TO RESPONSE:DON’T LET FEAR DEFEAT SCIENCE