International Society Of Heart And Lung Transplantation
INTERNATIONAL SOCIETY FOR HEART AND LUNG TRANSPLANTATION
“a Society that includes Basic Science, the Failing Heart, and Advanced Lung Disease”
International Society of Heart and Lung Transplantation
Advisory Statement on the Implications of
Pandemic Influenza for Thoracic Organ Transplantation
This advisory statement has been produced by the International Society of Heart and Lung
Transplantation to complement existing official guidance from national and international public health
agencies. Please refer to your local and/ or national guidance and use this statement as
complementary expert opinion on optimal management of patients pre and post thoracic organ
transplantation in preparation for or during an outbreak of Pandemic Influenza.
This statement has been prompted by the identification of a novel swine influenza A (H1N1) virus
causing illness in humans in Mexico, the United States, in multiple countries in Europe, Asia, Central
and South America, Australia and New Zealand. The World Health Organization (WHO) and the US
Centre for Disease Control (CDC) began monitoring this pandemic spread in real time on April 20,
2009, with updates on their websites daily. The pandemic threat is currently at Alert Level 5
(sustained community level outbreaks with person-to-person spread in at least 2 countries within one
WHO region) which is a strong signal that a pandemic is imminent, according to the WHO. This Alert
Level will be revised by the WHO in accordance with rates of spread around the world.
This Statement is relevant to:
Candidates Awaiting Heart or Lung or Heart-Lung Transplantation
Patients on Mechanical Circulatory Support (MCS)
Heart and Lung and Heart-Lung Transplant Recipients
Assessment of potential thoracic donor organs
Clinical Presentation
• Recognised symptoms of influenza infection include fever, headache, tiredness, cough, sore
throat, runny nose, body aches, diarrhoea, and vomiting. These are non-specific and have
similarities to seasonal, non-pandemic influenza and other community acquired respiratory
virus infections.
• Conditions which historically increase the risk of severe influenza infection include chronic
pulmonary, cardiovascular, renal, hepatic, hematological, or metabolic disorders and an
immunosuppressed state.
• There remain many unknowns about behavior of pandemic influenza virus in the pre and post
heart or lung transplant population and MCS patient population. The symptoms may present
differently, the incubation period may be longer or shorter and the infection may be more or
less severe.
30th Annual Meeting, April 21-24, 2010, Chicago, Illinois
31st Annual Meeting, April 13-16, 2011, San Diego, California
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INTERNATIONAL SOCIETY FOR HEART AND LUNG TRANSPLANTATION
“a Society that includes Basic Science, the Failing Heart, and Advanced Lung Disease”
Reducing Risk of Influenza Infection using Basic Infection Control Approaches
• Personal distancing: stay at least 3 feet (1 meter) or arms length from everyone and when in
public places, stay in well ventilated areas only.
• Cough etiquette: cough or sneeze into disposable tissue and dispose of immediately or if
unavailable cough into axilla rather than onto hands.
• Hand washing: wash hand after touching anyone or anything and use alcohol rubs with
intermittent soap and water scrubs for 20 seconds duration throughout the day.
• Monitor local community risk – News channels, national or international public health agency
websites.
• If pandemic influenza is present in the local community then avoid public gatherings and avoid
exposure to persons with non-specific illness.
• Remain up to date on other vaccines such as pneumococcal vaccination
Use of Face Masks by Immunosuppressed Patients in Public
• Surgical-style
face
masks might decrease episodes of contaminated hands reaching nose /
mouth area with subsequent reduction in infection risk
• Masks are thought to have some limited efficacy in reducing the exposure to infectious
droplets
• Masks should be worn by any infected patient and by a caretaker who is within 3 feet of an
infected person
• Correctly fitted masks are required by health care workers engaged in the assessment or care
of patients with suspected or proven pandemic influenza infection.
Practical Issues for Consideration
Designated Caregivers: Patient groups should clearly identify an adequate support system. This
includes a home caregiver for pre or post thoracic organ transplant recipients or MCS patients and/ or
family members should they also become infected.
Medication: Patients should ensure that they have adequate supplies of routine daily medications
especially maintenance immunosuppression for transplant recipients and other essential treatment for
chronic diseases like CHF, COPD, diabetes and hypertension, to last until a pandemic is over (up to 4
weeks if possible).
Travel: Non essential travel should be avoided by pre and post thoracic organ transplantation
patients when an influenza pandemic is threatened. The pandemic alert level of 5 reflects that a
30th Annual Meeting, April 21-24, 2010, Chicago, Illinois
31st Annual Meeting, April 13-16, 2011, San Diego, California
14673 Midway Road * Suite 200 * Addison, Texas 75001 * Tel: 972-490-9495 * Fax: 972-490-9499 * E-mail: ishlt@ishlt.org * WebSite: www.ishlt.org
INTERNATIONAL SOCIETY FOR HEART AND LUNG TRANSPLANTATION
“a Society that includes Basic Science, the Failing Heart, and Advanced Lung Disease”
pandemic is imminent. Data on community levels of infection with pandemic influenza is likely to lag
by at least 2-3 days. There cannot be certainty that a travelers destination will be infection-free
prospectively. Historically, if a patient travels to an area of significant community incidence of an
infection, they will be at higher risk of contracting the illness. Additionally they may have a more
severe illness and bring the illness back to their home community. At this point, the specific behavior
of the Influenza A (H1N1) is unknown, but the consequences of illness thus far have included
fatalities, as of 05/11/09, there have been 4694 cases with 54 deaths worldwide.
Managing Suspected Exposure or Suspected Infection
Patients pre and post thoracic organ transplantation and MCS patients are considered a “high-risk”
group for complications of pandemic influenza virus infection. If a patient believes they have been
exposed to a case of influenza they should consult their local healthcare provider to assess the need
for testing and evaluation for possible anti-influenza treatment or prophylaxis. The patient must also
inform their transplant or MCS centre. Patients must not present to their healthcare provider or
transplant centre unannounced in this situation. The 2008-2009 seasonal influenza vaccine is not
believed to offer protection against the Pandemic Influenza A H1N1 virus.
Antiviral chemoprophylaxis
Pre and post transplant recipients and MCS patients, both adults and pediatric, who are close
contacts of a person or persons with probable or confirmed pandemic influenza A (H1N1) should
receive antiviral chemoprophylaxis with either Oseltamivir (Tamiflu) or Zanamivir (Relenza) antiviral
agents in accordance with their national guidance.
If seasonal influenza is still active in the patient’s community, Zanamivir (Relenza) or Oseltamivir
(Tamiflu) plus rimantadine or amantadine should be used to provide adequate empiric treatment or
chemoprophylaxis for immunosuppressed patients that might have either the Pandemic Influenza A
(H1N1) of swine origin or the seasonal human Influenza A (H1N1) virus infection- a known potentially
lethal virus in this population.
Post-exposure antiviral chemoprophylaxis (Post EAC)
• A full risk assessment of the likelihood of exposure and the likely benefit of Post EAC to the patient
should be performed.
• If appropriate, treat with antiviral(s) at prophylactic dosing for 10 days after the last known
exposure to a symptomatic confirmed case of pandemic influenza infection.
• Post exposure prophylaxis should be considered for contacts during the infectious period (defined
as 1 day before until 7 days after the case’s onset of symptoms). However, the actual infectious
period for the Pandemic Influenza A ( H1N1) is, as yet, unknown.
• If the contact with a known case occurred more than 7 days earlier, then prophylaxis is not
30th Annual Meeting, April 21-24, 2010, Chicago, Illinois
31st Annual Meeting, April 13-16, 2011, San Diego, California
14673 Midway Road * Suite 200 * Addison, Texas 75001 * Tel: 972-490-9495 * Fax: 972-490-9499 * E-mail: ishlt@ishlt.org * WebSite: www.ishlt.org
INTERNATIONAL SOCIETY FOR HEART AND LUNG TRANSPLANTATION
“a Society that includes Basic Science, the Failing Heart, and Advanced Lung Disease”
necessary.
Pre--exposure protection
• The use of pre-exposure chemoprophylaxis in high risk populations during an influenza pandemic
is controversial due to the potential for the development of resistance to anti-viral agents. Local or
national policy should be followed.
Actions for the patient during suspected or proven influenza infection
• Stay at home. Patients with Pandemic influenza A (H1N1) should receive treatment with
antiviral agents. If patient is concerned about their condition, they should contact their
healthcare provider and transplant center to report symptoms and get advice.
• Hospitalization should occur if the physician has any doubt about patient’s ability to take
medications, remain hydrated, or if they are developing respiratory insufficiency or other
complications.
• Continue basic infection control measures in the home.
Actions for physicians during suspected or proven influenza infection:
• It is reasonable to initiate anti-viral treatment after diagnostic specimens have been obtained,
even if symptoms have been present for >48 hours. The data that antiviral medication needs
to be initiated within 48 hours of symptoms developing to have any effect applies to the non-
immunosuppressed population.
• Use Oseltamivir 75 mg po bid or Zanamivir 10 mg (2 x 5mg blisters) inhaled bid for 5 days or
until symptoms resolve, whichever is longer.
• If seasonal human Influenza A (H1N1) is also in the community, see above section on
antiviral chemoprophylaxis and follow local and international recommendations.
• Physician may elect to attenuate immunosuppression during active infection. This decision
should be individualized for each transplant patient by their transplant physician/team.
• Monitor recipients closely for allograft rejection and for co-infections such as Cytomegalovirus
activation or Pneumocystis jiroveci pneumonia (PCP) infection.
• Illness might progress rapidly. Physicians should be vigilant for secondary bacterial infections
including pneumonia.
30th Annual Meeting, April 21-24, 2010, Chicago, Illinois
31st Annual Meeting, April 13-16, 2011, San Diego, California
14673 Midway Road * Suite 200 * Addison, Texas 75001 * Tel: 972-490-9495 * Fax: 972-490-9499 * E-mail: ishlt@ishlt.org * WebSite: www.ishlt.org
INTERNATIONAL SOCIETY FOR HEART AND LUNG TRANSPLANTATION
“a Society that includes Basic Science, the Failing Heart, and Advanced Lung Disease”
Drug interactions
• Oseltamivir
and
Zanamivir do not have drug interactions with ciclosporine, tacrolimus,
mycophenolate, prednisone or sirolimus. There are no expected interactions with monoclonal
antibody induction agents or anti- thymocyte globulin. Oseltamivir needs to be adjusted for renal
impairment and Zanamivir should not be given to patients with COPD or at risk of bronchospasm.
• Rimantadine and Amantadine have a significant toxicity profile and should be given only with
expert guidance. Care with drug interactions and monitoring for adverse effects of these drugs is
needed if used in treatment or prophylaxis in this population.
Assessment of Thoracic Organ Donors during Pandemic Influenza A (H1N1)
• The risk assessment for any potential organ donor must be made at a local level with specific
input from ID or clinical microbiology specialists within the transplant unit.
• Potential organ donors, who have been diagnosed as having influenza, either clinically or by
virological diagnosis, should not be used as lung donors.
• Potential organ donors who have been diagnosed as having influenza but have received
appropriate anti-viral therapy could be considered as potential heart donors.
• In potential organ donors who die of other causes – a careful medical/social history should be
taken to determine if influenza symptoms were experienced by the patient. In such cases
expert ID or clinical microbiology advice should be obtained prior to organ procurement.
• Since the full virulence of pandemic influenza is not known, careful consideration should be
given to organ procurement in the presence of suspected infection.
These recommendations may be applied to patients pre and post thoracic organ transplantation,
MCS patients, and their transplant teams in preparation for or during an outbreak of ANY pandemic
influenza viral strain. Transplant teams must realize however that the clinical presentation and the
antiviral treatment recommendations may vary from strain to strain and local public health agency
guidance should be followed.
This statement was released jointly by
the International Society for Heart and Lung Transplantation’s Education Committee and
Scientific Council for Infectious Diseases
on 15th May 2009.
30th Annual Meeting, April 21-24, 2010, Chicago, Illinois
31st Annual Meeting, April 13-16, 2011, San Diego, California
14673 Midway Road * Suite 200 * Addison, Texas 75001 * Tel: 972-490-9495 * Fax: 972-490-9499 * E-mail: ishlt@ishlt.org * WebSite: www.ishlt.org