Ad Hoc Disease Transmission Advisory Committee: A Report to the OPTN/UNOS Board
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1 Ad Hoc Disease Transmission Advisory Committee: A Report to the OPTN/UNOS Board Dr. Michael Green, MD, MPH, Chair Dr. Daniel Kaul, MD, Vice Chair June 24-25, 2013 Richmond, VA
2 New PHS Guideline Update Released on-line through Public Health Reports on June 19 Journal publication release still anticipated July-August CDC hosting webinar introduction on June 25 Must be registered to attend Will be recorded, for viewing at a later date DTAC will complete page-by-page review to determine if any policy modifications or additions will be appropriate.
3 Committee Projects Completed Encephalitis Subcommittee Developed standard slide set meant to help members consider and recognize potential risk of CNS infection of unknown etiology Accompanies 2012 guidance document Toxoplasma Education Subcommittee Developed new electronic learning module educational tool to raise awareness regarding the importance of screening donors Hoping to partner with ISHLT to reach target audience of heart transplant teams
4 Ongoing Committee Projects Joint DTAC-OPO-Operations and Safety Subcommittee Addressing policy needs for re-running a match run when serologies change (anticipated Spring 2014 public comment) Joint DTAC-OPO Subcommittee Communicating new donor information learned post-transplant education vs. policy change still being discussed- a survey of OPOs and centers may be used (anticipated Spring 2014) Policy Subcommittee Developing modifications for deceased donor evaluation for public comment in Fall 2013
5 Ongoing Committee Projects Living Donor Policy Subcommittee Partnering with Living Donor Committee to address concerns in current language for infectious disease evaluation of potential living kidney (and liver) donors Developing guidance for other seasonally or geographically endemic diseases Completed WNV Guidance in time for mosquito season!
6 Changes in Classification Process for 2012 Intake and case management now housed in Dept of Evaluation and Quality Each case classified overall and by EACH organ recipient More useful data that may be helpful in utilizing organs that may have been otherwise discarded based upon trends/patterns DTAC members use an algorithm to classify Designed by Dr. Michael Nalesnik, a past vice-chair of the DTAC Ensures consistency in classification of cases
7 Ongoing Educational Efforts Guidance documents Manuscripts Abstracts and professional meeting presentations ATC NATCO ISHLT ICAAC
8 Potential Donor Derived Transmission Events (PDDTE) 250 Number of PDDTE Reviewed by DTAC*, *Additional reports are submitted, but not reviewed by full DTAC (duplicates, expected transmissions and other unnecessary reporting, etc).
9 2012 Potential Donor Derived Transmission Events Classified by DTAC Infections 126 Other 9* 198 PDDTE Classified Malignancies 63 Proven/ Probable 25 Possible 11 IWDT 18 Unlikely/ Excluded Proven/ Probable 7 Possible 3 IWDT 4 Unlikely/ Excluded * Nine Other (Non-Infection/Non-Malignancy) reported events classified as 1 Probable, 1 IWDT, and 7 Unlikely/Exclude.
10 Proven/Probable (PP) Transmissions for 2012 Cases Reports PP Cases Number of Transplants by Organ Type PP Recip/ Recip From PP Cases Kidney Liver Heart Lung Other Organs (IN, KP, PA) PP Recip/ Recip From PP Cases Malignancy /4 3/5 0/1 2/2 0/0 9/12 3 Bacteria /9 1/6 1/3 4/6 0/1 9/25 3 Fungus /5 0/1 1/2 2/3 0/0 6/11 3 Virus /8 2/5 2/3 2/2 0/0 10/18 1 Parasite and Amoeba Deaths From Disease /9 4/6 3/3 0/0 1/1 12/19 3 TOTAL /35 10/23 7/12 10/13 2/3 47/86 13 Note: There were nine additional non-infection/non-malignancy cases of which one was classified as proven/probable, with no deaths.
11 Proven/Probable (PP) Transmissions for 2012 Cases Reports PP Cases Number of Transplants by Organ Type PP Recip/ Recip From PP Cases Kidney Liver Heart Lung Other Organs (IN, KP, PA) PP Recip/ Recip From PP Cases Malignancy /4 3/5 0/1 2/2 0/0 9/12 3 Bacteria /9 1/6 1/3 4/6 0/1 9/25 3 Fungus /5 0/1 1/2 2/3 0/0 6/11 3 Virus /8 2/5 2/3 2/2 0/0 10/18 1 Parasite and Amoeba Deaths From Disease /9 4/6 3/3 0/0 1/1 12/19 3 TOTAL /35 10/23 7/12 10/13 2/3 47/86 13 Note: There were nine additional non-infection/non-malignancy cases of which one was classified as proven/probable, with no deaths.
12 Proven/Probable (PP) Transmissions for 2012 Cases Reports PP Cases Number of Transplants by Organ Type PP Recip/ Recip From PP Cases Kidney Liver Heart Lung Other Organs (IN, KP, PA) PP Recip/ Recip From PP Cases Malignancy /4 3/5 0/1 2/2 0/0 9/12 3 Bacteria /9 1/6 1/3 4/6 0/1 9/25 3 Fungus /5 0/1 1/2 2/3 0/0 6/11 3 Virus /8 2/5 2/3 2/2 0/0 10/18 1 Parasite and Amoeba Deaths From Disease /9 4/6 3/3 0/0 1/1 12/19 3 TOTAL /35 10/23 7/12 10/13 2/3 47/86 13 Note: There were nine additional non-infection/non-malignancy cases of which one was classified as proven/probable, with no deaths.
13 Cumulative Incidence of Disease Transmission: PDDTE Reported Through 2012 Involving Donors Recovered Deceased Donors Living Donors Deceased and Living Combined Donors recovered N (%) with PDDTE through (1.8%) 18 (0.07%) 593 (1.0%) N (%) with prov/prob PDDTE through (0.3%) 5 (0.02%) 112 (0.2%) recipients transplanted N (%) recipients with prov/prob disease 135 (0.2%) 4 (0.02%) 139 (0.1%) N (%) recipient deaths due to prov/prob disease 28 (0.03%) 1 (0.004%) 29 (0.03%)
14 Conclusions Continued increase in PDDTE reporting in 2012 Percent PDDTE with P/P transmissions remains low (17%) Cumulative incidence of P/P transmission in donors remains low (0.2%) Analysis of individual recipients identified parasites/amoeba as having highest transmission rate to exposed recipients (63%) with associated mortality Attention to outcome of individual recipients may: Potentially predict whether all exposed recipients are at equal risk of transmission Enhance our ability to develop strategies to reduce adverse events related to PDDTE
15 DTAC Membership Dr. Mike Green (Chair, Peds TID) Dr. Dan Kaul (Vice Chair, TID) Ms. Donna Ennis (Sr. TX Coord) Dr. Ed Dominguez (TID) Ms. Dianne LaPointe Rudow (TX Ad, LD) Dr. Yuk Law (Peds Cardiac) Dr. Tom Gross (Peds Hem/Onc) Dr. Camille Kotton (TID) Dr. Shimon Kusne (TID) Dr. Cameron Wolfe (TID) Dr. Rachel Miller (TID) Mr. Dave DeStefano (OPO Dir) Dr. Mary Klassen-Fischer (Anat Path) Dr. Walter Bell (Pathology) Dr. Martha Pavlakis (Nephrology) Dr. Tim Pruett (Abd TX Surgeon) Dr. Philip Ruiz (Pathology) Dr. Michael Souter (OPO Med Dir) Dr. Nicole Siparsky (TX Surgeon) Ms. Linda Weiss (OPO Lab Dir) Dr. Marilyn Menegus (Micro/Immunology) Dr. Scott Biggins (Hepatology) Dr. Emily Blumberg (Ex Officio) Dr. Sridar Basavaraju (CDC) Dr. Jim Bowman (HRSA) Dr. Melissa Greenwald (FDA) Dr. Bernie Kozlovsky (HRSA) Ms. Raelene Skerda (HRSA)
16 Questions? Thank you! Dr. Michael Green Shandie Covington Children s Hospital of UNOS Pittsburgh of UPMC Policy Analyst DTAC Chair DTAC Liaison Michael.Green@chp.edu shandie.covington@unos.org (412) (804) Special thanks to Sarah Taranto, Kimberly Parker and Cassandra Meekins, as well as the entire Committee!
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