New challenges and opportunities in organ donation Dr Paul Murphy National Clinical Lead for Organ Donation NHS Blood and Transplant 1 Outline • Performance 2013/14 • Updates – Ante mortem interventions – DCD heart retrieval – Extended DCD – Anencephaly – Neurological determination of death in infants < 2 months – Challenges to neurological determination of death • Current strategies – Family refusal – DCD triage – Organ utilisation – Regional Collaboratives Deceased donors and transplants in UK 4000 Donors Transplants 3509 3500 2916 3000 2500 2242 2197 2386 2384 2559 2655 3341 3118 2706 2000 1500 1000 751 765 793 809 899 959 1010 1088 1212 1320 1282 500 0 2004/05 2005/06 2006/07 2007/08 2008/09 2009/10 2010/11 2011/12 2012/13 2013/14 2014/15 Trends in UK donation Rolling 12 month numbers of DBD and DCD donors, 2008- to date 1400 Total 1200 DBD DCD 800 600 400 200 ar -0 8 Se p08 M ar -0 9 Se p09 M ar -1 0 Se p10 M ar -1 1 Se p11 M ar -1 2 Se p12 M ar -1 3 Se p13 M ar -1 4 Se p14 M ar -1 5 0 M number 1000 Eligible donors Eligible DBD donors Eligible DCD donors Eligible DBD or DCD donors 3000 2500 number 2000 1500 1000 500 0 Apr 10 - Oct 10 - Apr 11 - Oct 11 - Apr 12 - Oct 12 - Apr 13 - Oct 13 - Apr 14 - Oct 14 Sep 10 Mar 11 Sep 11 Mar 12 Sep 12 Mar 13 Sep 13 Mar 14 Sep 14 Mar 15 Progress against PDA metrics Referral and BSD testing DBD DCD 100 Referral 90 Referral rate (%) 80 70 60 50 40 30 20 10 BSD testing BSD testing rate (%) 0 2007-8 2008-9 2009-10 2010-11 2011-12 2012-13 2013-14 2014-15* 2007-8 2008-9 2009-10 2010-11 2011-12 2012-13 2013-14 2014-15* 100 90 80 70 60 50 20 14 /1 5* 20 13 /1 4 20 12 /1 3 20 11 /1 2 20 10 /1 1 20 09 /1 0 20 08 /0 9 20 20 07 /0 8 30 20 06 /0 7 20 05 /0 6 20 04 /0 5 20 03 /0 4 consent / authorisation rate (%) Progress against PDA metrics Consent / authorisation 80 70 60 50 40 DBD DCD 10 0 Age of deceased DCD donors • • • Proportionally fewer donors are aged 70+ For kidneys, there appears to be less appetite to use the higher risk donors in the most recent year, while for livers there is no such trend. Kidney offer decline rates are higher in the last two years for extended criteria donors. 100 90 3 15 3 14 3 13 3 17 5 15 80 70 25 26 22 60 26 24 8 10 11 12 16 18 20 23 22 22 24 24 50 40 30 49 50 53 48 50 0 8 7 8 5 7 22 70+ 25 26 22 25 6069 46 42 38 37 37 39 4 4 4 3 4 3 20 10 11 2004/05 2005/06 2006/07 2007/08 2008/09 2009/10 2010/11 2011/12 2012/13 2013/14 2014/15 2014/15 Based on activity to 1 March Some features of current position • 7% fall in donor numbers from peak – Both DBD and DCD • No substantial deterioration in donor pool, referral or testing – Possible small fall in DBD pool – 25% of potential DCD not referred • Little progress with consent / authorisation – Slight fall in both DBD and DCD in 2014/15 • More cautious approach to older / higher risk kidney donors – Kidney offer decline rates are higher in the last two years for extended criteria donors DRAFT Update: ante mortem interventions in DCD • Legal guidance issued in 2009 - 11 – Conservative – Effective prohibition on ante-mortem heparin • Call for revision in 2012 / 2013 by UK DEC – Generic overarching guidance – Separate documents covering specific interventions (e.g. heparin, extubation) – Specific recommendations regarding heparin • Further evidence required by Department of Health – Risks and benefits – Clinical and public acceptability – NHSBT asked to conduct this review Physiological changes following treatment withdrawal • Can a point of ‘no-return’ be identified following treatment withdrawal? – Does the patient always die if BP goes below a certain level? – Does donation always happen if BP goes below a certain level? • Is there time to give heparin once point of no return is identified for it to have a systemic effect? • What happens to non-proceeding DCD donors? – Do all potential DCD donors die following treatment withdrawal? Systolic BP in proceeding DCD donors, all regions 350 systolic BP (mmHg) 300 250 200 150 100 50 0 0 20 40 60 80 100 120 140 time after treatment withdrawal (minutes) 160 180 200 Timings in proceeding DCD donors Systolic BP of 50 mmHg to asystole (minutes) Minimum Maximum Mean 5.9 8.1 Median 5 6 Range 1 – 56 Systolic BP of 90 mmHg to asystole (minutes) Minimum Maximum Mean 12.8 16.2 Median 8 12 Range 1-86 Minimum: time from first recording below selected BP to asystole Maximum: time from last recording over selected BP to asystole Systolic BP, non-proceeding donors, n=153 300 systolic BP 250 200 150 c 100 50 0 0 20 40 60 80 100 120 minutes after treatment withdrawal 140 160 180 Non-proceeding DCD donors with one or more SBP < 90 mmHg (n=13) 300 270 240 died 13 hours died 31 hours died 8 hours 210 systolic BP died 29 hours died 3 hours 180 died 7 hours died 4 hours 150 died 5 hours died 1.5 hours 120 died 114 hours died 120 hours 90 died 12 hours died 7 hours 60 30 0 0 20 40 60 80 100 120 140 160 time after treatment withdrawal (minutes) 180 200 Time to death in non-proceeding DCD donors (n=153, data on three patients missing) 60 52 50 number 40 30 23 22 17 20 8 7 2 1 0 0 0 0 0 0 1 1 0 day 17 day 18 day 19 day 20 day 21 day 22 day 23 day 11 0 day 16 2 day 15 2 day 14 1 day 13 0 day 10 3 day 9 5 day 8 10 3 0 Home day 12 day 7 day 6 day 5 day 4 day 3 day 2 13-24 hours 0 - 12 hours time after treatment withdrawal Update: Heart retrieval from DCD donors UK pilots • 2 pilots • Normothermic regional perfusion assisted – Papworth – 3 centres in Eastern region – 2 successful transplants to date • Standard DCD retrieval – Papworth and Harefield – Eastern and South East regions – Transthoracic echo (Harefield) Update: extended DCD pilot • Andre Vercueil, King’s; Roberto Cacciola, Royal London • NRP to support abdominal organ retrieval for up to 9 hours after stand down • Cannulae sited on ICU after death • No ante mortem interventions • 1 proceeding case so far – Organs poorly perfused and so rejected after retrieval – Family grateful for extended opportunity – Positive staff feedback • ?? Benefits of – Heparin – Femoral guidewires Update: organ donation from babies with anencephaly • Twin pregnancy • Successful donation of kidneys and heart valves from an anencephalic infant in April 14 • Delivery ≡ treatment withdrawal • Baby died after 100 minutes – Death diagnosed after 5 minutes asystole • Assessment of renal function limited to size on USS and lack of oligohydramnios • Media coverage at baby’s anniversary – c.15 000 on-line registrations National CLOD in Big Brother Chair Update: organ donation from babies with anencephaly • Twin pregnancy • Successful donation of kidneys and heart valves from an anencephalic infant in April 14 • Delivery ≡ treatment withdrawal • Baby died after 100 minutes – Death diagnosed after 5 minutes asystole • Assessment of renal function limited to size on USS and lack of oligohydramnios • Media coverage at baby’s anniversary – c.15 000 on-line registrations Update: diagnosis of death by neurological criteria in infants < 2 months • AoMRC (2008) applies from 37 weeks gestation to 2 months, with two additional cautions • Available at http://www.rcpch.ac.uk/system/files/p rotected/page/DNC%20Guide%20FI NAL.pdf Update: DNC in infants < 2 months Additional cautions • In post-asphyxiated infants, or those receiving intensive care after resuscitation, a period of at least 24 hours of observation during which the preconditions necessary for assessment for DNC should be continuously present, should elapse before clinical testing for DNC. If there are concerns about residual drug-induced sedation, then this period of observation may need to be extended • A stronger hypercarbic stimulus is used to establish respiratory unresponsiveness. Specifically, there should be a clear rise in PaCO2 levels of >2.7kPa (>20 mm Hg) above the base line with no respiratory response at that level. Update: challenges to neurological determination of death by organ retrieval teams • 6 incidents reported Nov 14 – Feb 15 • Nature – – – – Apnoea test (starting CO2) Hypernatraeamia Interval between testing Lack of microbiological characterisation • Outcome – Retrieval delayed until tests repeated – Considerable distress in donor hospitals • Root cause analysis – Education and training deficits – Variation in practice in critical care – Issues with documentation Apnoea testing in Midlands, Jan-Mar 15 1st apnoea test 2nd apnoea test 16 14 12 PaCO2 PaCO2 10 8 6 4 2 0 Pre-disconnection end of apnoea test 18 DBDs 6 forms had no CO2 data 7 tests completely compliant 4 tests partially compliant 1 set of tests non compliant Pre-disconnection end of apnoea test National Standards for Organ Retrieval 5.11 Before embarking on the retrieval operation, the lead retrieval surgeons must review the patient’s medical notes. In particular they must: • Have a clear understanding of the donor information prior to the start of the retrieval; • Check the identity, blood group and virology status of the donor; • Check that brain stem death or confirmation of cardiac death has been confirmed and documented correctly; • Check that appropriate consent/authorisation has been documented for the organs and tissues to be retrieved; Interim proposal • Additional form • Completed by ICU consultant • Confirmation that death has been diagnosed and confirmed by neurological criteria • Cause, time and place of death • No other clinical information • Supported by NODC and NRG • Consulting HTA International family refusal rates, 2011 Consent / authorisation for DBD Consent / authorisation for DBD Collaborative requesting Donation after brain-stem death Donation after circulatory death 100 90 SNOD involvement 80 consent / authorisation 90 80 70 60 60 50 % 70 50 40 30 30 20 20 10 10 0 0 20 05 /6 20 06 /7 20 07 /8 20 08 /9 20 09 /1 0 20 10 /1 1 20 11 /1 2 20 12 /1 3 20 13 /1 4 20 14 /1 5* 40 20 05 /6 20 06 /7 20 07 /8 20 08 /9 20 09 /1 0 20 10 /1 1 20 11 /1 2 20 12 /1 3 20 13 /1 4 20 14 /1 5* % 100 UK Overall SN-OD consent/authorisation rate, when not on ODR, SNOD consent rates whitepatients, adult patients non-BAME notonly on ODR 1 Jan 2012 to 31 Dec 2013, where no doubt over SN-OD name • • • • • • • 100 • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • 80 Consent/authorisation rate (%) • 60 40 20 • • • 0 0 • • 5 10 15 20 25 30 35 Number of approaches 40 45 50 55 60 Outcome of family approach Improving how we ask Donation after brain-stem death 100 90 consent / authorisation 80 SNOD involvement 70 50 40 30 – Has to be the right SNOD – Designated requester pilot in North West and Yorkshire 20 10 – May require review of SN-OD deployment 0 20 05 /6 20 06 /7 20 07 /8 20 08 /9 20 09 /1 0 20 10 /1 1 20 11 /1 2 20 12 /1 3 20 13 /1 4 20 14 /1 5* % 60 • Continued commitment to collaborative requesting • Values based cohort SNOD recruitment • Six-month pilot of ALS review of refusals in Midlands, Yorkshire and London teams DCD triage? 1 April 2013 to 31 March 2014 Respiratory failure 245 referrals, 140 attendances 28 NORS attendances, 25 donors 37 kidneys, 1 liver transplanted Cancer, other than brain tumour 280 referrals, 106 Attendances, 0 NORS attendances 0 donors Renal Failure 30 referrals, 10 Attendances, 0 NORS attendances 0 donors Multi Organ Failure 1113 referrals, 471 attendances, 3 NORS attendances 3 donors 5 kidney transplants Septicaemia 247 referrals, 101 attendances, 3 NORS attendances, 3 donors, 1 kidney transplant MOF/ Cancer/ Sepsis/Renal failure as a cause of death 688 SNOD attendances 6 NORS attendances 6 transplants Improving donor / organ utilisation • DCD heart retrieval • Phase II of Scout project • Ante-mortem interventions in DCD – Heparin at point of no return • Novel technologies – In-situ normothermic regional perfusion – Ex-situ perfusion 100 90 80 70 60 50 40 30 20 10 0 16 24 53 7 20 22 51 7 3 16 28 50 4 3 17 31 44 6 7 15 9 15 16 25 28 26 23 23 25 22 33 31 31 29 33 3 3 3 3 3 21 23 24 13 15 26 25 22 47 8 43 4 24 • Peer review of transplant centres • Accredited training for retrieval surgeons DRAFT Initial UK framework 8000 7877 7997 7655 7000 7800 7288 6698 6000 NHS Blood and Transplant 7636 7219 7026 Donors Transplants Transplant list 6142 5673 Number 5000 National ODO Employment of coordinators Commissioning of retrieval Audit Public engagement Education and training Departments of Health 48% Acute hospitals More patients having their wishes to donate recognised, fulfilled and maximised 3514 2912 3000 Clinical leads Embedded coordinators Donation Committees Funding Resolution of ethical and legal obstacles Regulation Public recognition 4000 2396 2241 2196 2385 2381 2552 2645 3112 2695 2000 1000 793 899 1088 764 959 751 809 1010 770 2003-04 2004-05 2005-06 2006-07 2007-08 2008-09 2009-10 2010-11 2011-12 1212 1320 2012-13 2013-14 0 The emerging UK framework for donation NHS Blood and Transplant National ODO Employment of SNODs Commissioning of retrieval Audit Public engagement Education and training CLODs SNODs Donation Committees Funding Resolution of ethical and legal obstacles Regulation Public recognition Donor hospitals Departments of Health and Professional Societies Regional Acute hospitals Collaboratives More patients having their wishes to donate recognised, fulfilled and maximised Service improvement in deceased donation • Timely identification and referral – Emergency Department • Brain-stem death testing • Collaborative requesting • Streamlining DCD What are we trying to achieve? How will we know that change is an improvement? What changes can we make that will result in improvement? • Physiological optimisation of the DBD donor act plan study do