Michael Ison USA - Monday 28 - Traceability and Biovigilance


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Michael Ison USA - Monday 28 - Traceability and Biovigilance

  1. 1. An Update on Donor-Derived Disease Transmission ThroughOrgan Transplantation in the USA Michael G. Ison, MD MS Associate Professor Divisions of Infectious Diseases & Organ Transplantation 2011 Organ Donation Congress – Buenos Aires, Argentina
  2. 2. Disclosures• Research Support° ADMA, Adamas, BioCryst, Chimerix, GlaxoSmithKline, Roche, ViraCor*• Paid Consultation Abbott, Abbott Molecular*, Astellas*, Biogen Idec, Crucell, ViraCor*• Unpaid Consultation BioCryst, Biota, Cellex, Clarassance, GlaxoSmithKline, MP Bioscience*, NexBio, Roche, Toyama, T2 Diagnostics*• Data & Safety Monitoring Board Participation Chimerix, NexBio As of 11/22/11; °Paid to Northwestern University; *Related to topic.
  3. 3. AcknowledgmentsDTAC data was supported wholly or in partby Health Resources and ServicesAdministration contract 234-2005- 370011C.The content is the responsibility of theauthors alone and does not necessarilyreflect the views or policies of theDepartment of Health and Human Services,nor does mention of trade names,commercial products, or organizations implyendorsement by the U.S. Government.
  4. 4. Case 1: Something Rare?• 54 yo WM with HBV/HCV/HCC• Day 5: Fever to 102.4, mild frontal HA since Tx• IS: ATG, Tacrolimus, Azathioprine• Abx: Pip-Tazo, HBIg, 3TC, Famciclovir, TMP-SMX• SH: Suburbs, Iron worker• PE: Non-focal except for a tender RUE peripheral IV catheter
  5. 5. Case 1: Something Rare?• Continued with fever, LFTs increased• Seizure (? Hypoxemic)• Progressive “sepsis” with elevated LFTs and renal dysfunction• Call from another Transplant ID doctor: “how is your recipient doing?”
  6. 6. The CulpritFischer et al. N Eng J Med. 2006;354:2235-2249.
  7. 7. Case 2: Something Common?• Patient is a 56 yo WM• Underwent OHT November 2005  Toxo D+/R–, CMV D+/R–  Pyramethamine-Sulfadiazine  Valganciclovir• 9 Days Post-Transplant  Donor has + blood cultures drawn the day prior to donation  Positive for Pseudomonas aeruginosa• What Went Right? What Went Wrong?  Took several days to convey results to recipient centers  Patient was receiving ciprofloxacin for a probable UTI, which covered the bacteria with no serious sequellae
  8. 8. Case 3: Refocusing on Risk• One recipient was identified with post-transplant HCV & HIV infection with no obvious risk factors and negative pre-transplant testing• Reported to OPO, UNOS, and CDC• Donor – Lookback Assessment  Negative serology for HIV & HCV  Appropriately labeled as “high risk” by PHS Guidelines  Subsequent testing of post-transfusion serum was + for HIV and HCV by PCR• All other recipients tested + for HIV & HCV Ison et al. Am J Transplant. 2011; 11: 1218–1225
  9. 9. Case 4: Living Donors Are Not Immune MMWR. 2011; 60: 297-301.
  10. 10. Unique Features of Organ Procurement • Restricted timeline (typically 24 hours) • Different Screening Paradigm - Not “Zero Risk” • Donor History  Second Hand Story  Lack of Standardization  Incomplete Data Collection • Serology-based Screening • Variable NAT capacity and practiceIson et al. Am J Transplant. 2009; 9: 1929-1935. Ison & Nalesnik. Am J Transplant. 2011; 11: 1123–1130.
  11. 11. A Significant Organ Shortage Exists 2009 DATA Organ Transplants 28,465 Waitlist Candidates 105,567 Deaths on Waitlist 9,848*Waiting list deaths includes removals for death, too sick to transplant, and those non-transplanted removals identified to have died within seven days of removal from linkage to SSDMF data. Based on OPTN data as of April 16, 2010.
  12. 12. A Delicate BalanceOrgan Availability Patient Safety
  13. 13. Current US Donor-Derived Disease Policy• Policy 2: Focused on Donor Screening  Review of donor medical/social history  Defines donors at increased risk of transmitting infections  Defines required donor screening (serologic)• Policy 4: Focused on recognizing and reporting disease transmission  Requirement to inform recipients of new data relative to risk  „When a transplant program is informed that an organ recipient at that program is confirmed positive for or has died from a transmissible disease or medical condition for which there is substantial concern that it could be from donor origin, the transplant program must notify by phone and provide available documentation, as soon as possible and not to exceed one complete working day, to the procuring OPO‟  Patient Safety Contact (required for each OPO and TC) http://optn.transplant.hrsa.gov/policiesAndBylaws/policies.asp
  14. 14. Disease Transmission Advisory Committee• Workflow  Report made to Patient Safety Staff o Prepare summary of event o Redact identifiers o Upload key materials to SharePoint Server  E-mail based discussion o Initial e-mail sent to all members o Ongoing electronic discussion  Day 45 Follow-up Reports submitted  Special Cases o Reportable Diseases: Inform CDC o Event-Specific Conference Calls  Monthly Conference Calls & Bi-Annual Meetings Ison et al. Am J Transplant. 2009; 9: 1929-1935.
  15. 15. DTAC Members as of July 2011Dr. Emily Blumberg, Chair (TID) Dr. Michael Green, Vice Chair (Peds TID)Ms. Carrie Comellas (TX Coordinator) Dr. Edward Dominguez (TID)Dr. Afshin Ehsan (Thoracic TX Surgeon) Mr. Barry Friedman (TX Administrator)Dr. Thomas Gross (Oncology) Dr. Daniel Kaul (TID)Dr. Simone Kushne (TID) Dr. G. Marshall Lyon (TID)Dr. Rachel Miller (TID) Ms. Samantha Mitchell (OPO)Dr. Michael Nalesnik (Pathology) Dr. Volker Nickeleit (Pathology)Dr. Timothy Pruett (Abd TX Surgeon) Dr. Phillip Ruiz (Pathology)Dr. Michael Souter (Tx Anesthesiology) Ms. Linda Weiss (Dir of OPO Lab Services)Dr. Betsy Tuttle Newhall (Abd TX Surgeon) Dr. Russell Wiesner (Hepatology)Dr. Jim Bowman (Ex Officio, HRSA) Dr. Bernard Kozlovsky (Ex Officio, HRSA)Ms Raelene Skerda (Ex Officio, HRSA)OPTN Staff: Shandie Covington, Robert Metzger, MD, Kimberly Parker, Sarah Taranto, Kimberly Taylor, RNOPTN
  16. 16. Potential Disease Transmission Cases Reported to DTAC200 176*180 152 152160140 102120 97100 80 60 60 40 7 20 0 2005 2006 2007 2008 2009 2010 2011OPTN *Estimated based on 161 reports through November 21, 2011.
  17. 17. Potential Disease Transmission Reports for Deceased Donors 3/2006-12/2010 by Donor Service Area (DSA)Number of Donor Reports 1 DSA with ZERO reports Individual DSAs OPTN
  18. 18. Percent of Deceased Donors Recovered2008-2009 Reported to DTAC by RegionOPTN
  19. 19. Potential Disease Transmission Reports for Deceased Donors During 2010 by DSANumber of Donor Reports 12 DSAs with ZERO reports Individual DSAs OPTN
  20. 20. Malignancy Reports: 2005-2010 Malignancy # of Donor Reports # of Recipients with # of DDD-Attributable Confirmed Transmission Recipient Deaths Renal Cell Carcinoma 78 9 1 Lung Cancer 15 10 7 Lymphoma 11 6 2 Thyroid Carcinoma 11 0 0 Melanoma 7 4 3 Glioblastoma multiforme 7 1 1 Liver Cancer 6 3 2 Prostate 6 1 0 Neuroendocrine 5 2 2 Pancreas 2 3 0 Ovarian Carcinoma 2 2 0 Other ** 35 0 0 Total 185 34 17 Malignancies **Other reported malignancies without confirmed transmission: angiomyolipoma, astrocytoma, breast, colon carcinoma, dermatofibrosarcoma protuberans, Kaposi‟s sarcoma, leukemia, medulloblastoma, mesothelioma, myeloid sarcoma, pinealoblastoma,, liposarcoma, gastrointestinal stromal tumor (GIST) spindle cell CNS carcinoma, carcinoma not otherwise specified (4), urothelial carcinoma.OPTN
  21. 21. Infection Reports: 2005-2010 Disease # of Donor # of Recipients with # of DDD-Attributable Reports Confirmed Transmission Recipient Deaths Virus∞ 122 34 9 Bacteria* 75 31 9 Fungus° 56 37 10 Mycobacteria§ 37 11 2 Parasitic† 30 18 6 Total Infections 320 131 36 ∞Viruses: Adenovirus, HBV, HCV, HEV, HIV, HTLV, herpes simplex, influenza, LCMV, Parainfluenza (PIV)-3, Parvovirus B19, rabies, West Nile Virus °Bacteria: Acinetobacter, Brucella Enterococcus (including VRE), Ehrlichia spp, E. coli, Gram Positive Bacteria, Klebsiella, Legionella, Listeria, Lyme Disease, Nocardia, Pseudomonas, Rocky Mountain Spotted Fever, Serratia , S. aureus (MRSA), Streptococcus spp, Syphilis, Veillonella; bacterial meningitis & bacterial emboli ° Fungi: Aspergillus spp, Candida spp, Coccidioides imitis, Cryptococcus neoformans, Histoplasma capsulatum, zygomyces § Mycobacteria: Tuberculosis, Non-TB Mycobacteria †Parasites:Babesia , Balmuthia mandrillaris, Chagas (Trypanosoma cruzi), Naegleria fowleri, schistosomiasis, strongyloidesOPTN
  22. 22. Lessons Learned: DTAC Data • Bacterial Transmissions  Likely under-recognized & under-reported  Often involves resistant bacteria  Follow-up of outstanding culture data • Fungi  Endemic mycoses & Cryptococcus increasing  High morbidity and mortality • Mycobacteria • Parasites  Increase in Strongyloides, Chagas, & Amoeba • Viral Transmissions  Increased recognition of PB19, LCMV  Need to use NAT to diagnose transmission, esp for HCVIson et al. Am J Transplant. 2009; 9: 1929-1935. Ison & Nalesnik. Am J Transplant. 2011; 11: 1123–1130.
  23. 23. Lessons Learned: DTAC Data • Communications  Inefficient systems in place  Delays are common • Poor systems for recognizing DDD  No cluster analysis  Severe outcomes not recognized by all recipient teams  Variable recognition and report  Management of positive cultures/result information locally • Increased risk donors  Variable definitions used  Variable understanding of risk  Variable follow-up of recipients • Living donorsIson et al. Am J Transplant. 2009; 9: 1929-1935. Ison & Nalesnik. Am J Transplant. 2011; 11: 1123–1130.
  24. 24. Michael G. Ison, MD MSQuestions? 312-695-4186 mgison@northwestern.edu I am a registered organ donor! Are you?