RISK ASSESSMENT OF TRANSPLANTING RENAL ALLOGRAFTS

1
Marek Nowicki, PhDNational Institute of
Transplantation
I have no financial relationships to disclose
within the past 12 months relevant to my
presentation My presentation does/does not
include discussion of off-label or
investigational use
2
Testing for antibodies and evaluating the risk
factors for exposure to T. cruzi among organ
donors in S. California single site experience

• Marek Nowicki1, Claudia Chinchilla1, Tom Mone2,
  Dem Brucal1, Maria Stadtler2, and Robert Mendez1
• 1National Institute of Transplantation, Los
  Angeles, CA and 2OneLegacy, Los Angeles, CA

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What is Chagas Disease?

• A chronic parasitic infection cause by the
  flagellate protozoa Trypanosoma cruzi.
• T. cruzi is carried by insects of the Reduviidae
  family (aka barbeiros, chupão, vinchucas or
  chupança) and also transmitted through blood
  transfusions, organ transplants, and
  congenitally.
• T. cruzi world-wide
• Endemic to most of South and Central America
  1618 million cases
• 25 of the inhabitants of Latin America at risk
• 25 to 30 infected will progress to irreversible
  cardiac, and esophageal/colonic pathology,
  causing considerable morbidity and mortality.

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Background

• March, 2002 - a case of three solid-organ
  transplant recipients received the parasite from
  the donor
• February, 2006 - 2 cases of acute Chagas disease
  in heart transplant recipients (Los Angeles, CA)
• CDC estimates
• 25,000 - 100,000 Latinos in the US infected with
  T. cruzi
• 360,000 South and Central Americans immigrate to
  the US annually

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Background (2)

• July, 2006 Ortho Clinical Diagnostic introduced
  in Europe a new diagnostic test for Chagas
  disease
• February, 2007- Ortho Diagnostic EIA is licensed
  in the US
• April, 2007 National Institute of
  Transplantation Laboratory began testing all
  OneLegacy donors

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Initial evaluation (2004)

• 404 donors tested using the Hemagen EIA assay,
  the only FDA approved test for the diagnostics of
  Chagas disease in the US at that time
• 6 initially reactive, 4 repeatedly reactive
• 3 send out for confirmatory testing (CDC)
• 1 (0.25) RIPA confirmed

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Aim

• To evaluate the prevalence of donors with
  risk factors for exposure to vectors carrying T.
  cruzi using a questionnaire asking donors
  families for self-reported past contacts with
  endemic areas

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Material and Methods

• We used a modified questionnaire originally
  developed by Galel et al. (Transfusion, vol. 36,
  No. 3, 1996)
• Our questionnaire included 5 questions assessing
  the risk of the prospective organ donors
  exposure to vectors potentially carrying parasite
  and/or diagnosed with Chagas disease

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Questionnaire

• Question 1 Donor diagnosed with Chagas
  disease in the past?
• Question 2 Donor traveled to the country
  where T. cruzi is endemic?
• Question 3 Donor spent 6 months in the
  country where T. cruzi is endemic?
• Question 4 Donor stayed in rural area?
• Question 5 Donor stayed in housing type
  preferred by the vector?

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Material and Methods

• We applied this tool to 491 cases of organ donors
  (donor families approached 09/06 and 11/07)
• Donors were from S. California area (Kern, San
  Bernardino, Santa Barbara, Los Angeles, Ventura,
  Orange, and Riverside counties)

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Material and Methods contd

• We tested all 491 donors using Ortho Diagnostic
  EIA detecting antibodies to T. cruzi
• Since Chagas testing implementation we tested a
  total of 512 donors

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Results self-reported risk

• 1 questionable self-reported Chagas case (EIA-,
  CNR)
• 43 were Latinos
• 49 donors were reported to have traveled to
  areas where T. cruzi is endemic
• 20 donors were reported by their families to
  have stayed in the endemic area for more than 6
  months
• 15.5 stayed in rural areas
• 11.4 donors was reported by the family to have
  lived for an extended time in housing potentially
  infested by the vectors of Chagas disease

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Results (2) EIA serology

• 3 donors (0.6) tested positive for antibodies to
  T. cruzi by EIA
• 1 donor was reported as indeterminate when
  tested by the confirmatory assay (IFA RIPA) and
  his status is unclear

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Results (3) EIA reactive donors characteristics

• Donor 1 47 years old Latino born in Guatemala,
  extended stay in Mexico
• Donor 2 31 years old Latina with history of
  travel to the endemic area
• Donor 3 56 years old Latino with history of
  travel and extended stay in the endemic area

Indeterminate by RIPA
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Conclusions

• The estimated risk of exposure to the vectors
  carrying T. cruzi is higher than previously
  reported
• Our finding underscores the need to monitor this
  new and emerging infection risk among Southern
  California organ donors.
• Our findings suggest that self-reported risk
  assessment tools will results in an unacceptable
  rate of deferred donors.
• In areas where there is a high number of
  immigrants from T. cruzi endemic countries,
  screening for anti-T. cruzi donor antibodies
  (EIA) is beneficial and recommended.

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Acknowledgments

• We expresses our thanks to donors families, for
  giving the gift of life, the gift of knowledge,
  and their help in making this project to happen.
• OneLegacy OPO
• Department for Family Services (FCCs, Jeff
  Fleming)
• Education Department (Stephanie Collazo, Jim
  Trisch)
• Research Project Management in OneLegacy
• Administrative and Executive Assistance
• Administration (Tom Mone, Renee Hawthorne)
• National Institute of Transplantation
• Laboratorians and NIT staff