Annual Fall Meeting November 13, 2016

Annual Fall Meeting November 13, 2016
6:30pm Welcome J. Kirklin/M. Everitt 6:40pm Steering Committee Report M. Everitt 6:50pm DCC Update J. Kirklin 7:05pm Web Based Data Entry D. Naftel 7:20pm Database Committee Report M. Richmond 7:35pm Foundation Update C. Collum/B. Wilk/R. Gajarski 7:50pm Risk Factor Model K. Schumacher 8:05pm Heart Failure Simulation B. Feingold 8:10pm iPHFR R. Gajarski 8:15pm Break 8:30pm Pedimacs Report B. Blume 8:40pm Scientific Committee Report D. Hsu 8:50pm Scientific Committee Sponsored Workshops 9:35pm New Business 9:45pm Adjourn

Elizabeth P. Pruitt, MSPH
PHTS Risk Model David C. Naftel, Ph.D. Elizabeth P. Pruitt, MSPH Charles Canter Ronald Woods J. William Gaynor James K. Kirklin Kurt Schumacher, MD, MS

PHTS: Transplants: 1999 - 2013 Follow up: Dec. 31, 2014
Risk Factors for Graft Loss at One Year Post-Transplant (1999 – 2014) Introduction Earlier PHTS Models (Schumacher et al) SRTR Pediatric Model Current Analysis: Cohorts, Events, Methods Congenital Diagnosis Model Cardiomyopathy Model Next Steps

Introduction PHTS is good at risk factor analysis and modeling.
SRTR also models risk and risk of 1-year graft loss to assess center performance. Many have expressed concern about the SRTR models for pediatric heart transplant Can we use PHTS to find a better way to model risk that could help the SRTR in assessing center performance? 12/25/2018

Previous PHTS Models Many
Most recently PHTS modeled risk of 1-year graft loss PHTS cohort was stratified by disease type – cardiomyopathy vs. congenital Recipient and Recipient+Donor models Modeled with transplants from Validated with transplants from 12/25/2018

Cardiomyopathy models performed well, C-statistics between 0.7 – 0.8 Congenital models performed OK, C-statistics between 0.6 – 0.7

Clinically useable, easy to understand Clear differences in significant risk factors between types of heart disease Validated against another cohort of patients

SRTR Models SRTR uses the OPTN database
Over a given period of time, SRTR uses all available data to produce the best fit model for the cohort SRTR does not stratify by disease type though it appears risk factors differ by disease No validation against other data 12/25/2018

SRTR Model

Not very easy to think about clinically
SRTR Summary Large model Not very easy to think about clinically Possibly includes non-relevant items to maximize C-statistic at the expense of obtaining a model that best explains the data? Overfitted? Less able to predict new observations? Less precision? Can’t know because there is no validation 12/25/2018

Cohort Transplants 4673 Transplants 847 Transplants 3271 Congenital HD 1502 Transferred within 6 months 76 Included Congenital HD 1426 Cardiomyopathy 1592 89 Included Cardiomyopathy 1503 Other Etiology 177 16 Transplants 2014 340 Retransplants 215

93% 85%

94% 86%

Next Step – PHTS and SRTR together
12/25/2018

Congenital Cardiomyopathy PHTS SRTR Demographics: Sex X Race Age Primary Dx: Cardiomyopathy - Primary Dx: Congenital Heart Disease Single Ventricle Fontan Dilated CMP X Restrictive CMP - Hypertrophic CMP BSA BMI Note: All continuous variables had log and squared transformations to test “nonlinear” effects. O = Not looked at in KS model but available in PHTS data X = Looked at in KS model and not significant X = Significant in final KS model C = Suggested addition by Charlie Canter

Congenital Cardiomyopathy PHTS SRTR Status at Transplant: UNOS Status X X Ventilator X In Hospital O Intensive Care VAD ECMO Inotropes, high or low Previous Surgery Number of Previous Surgeries C PRA Dialysis Since Listing O (2010) PA (dia) PCW Total Bilirubin Serum Creatinine Serum BUN Serum Albumin Prospective Crossmatch Year of Transplant O = Not looked at in KS model but available in PHTS data X = Looked at in KS model and not significant X = Significant in final KS model C = Suggested addition by Charlie Canter Note: All continuous variables had log and squared transformations to test “nonlinear” effects.

Congenital Cardiomyopathy PHTS SRTR Clinical Condition at Listing: Blood Type X HBsAb O Note: All continuous variables had log and squared transformations to test “nonlinear” effects. O = Not looked at in KS model but available in PHTS data X = Looked at in KS model and not significant X = Significant in final KS model C = Suggested addition by Charlie Canter

Congenital Cardiomyopathy PHTS SRTR Donor Demographics: Donor Sex X X Donor Race X Donor Age Donor BSA Donor BMI Ischemic Time Donor Vasoactive Support Note: All continuous variables had log and squared transformations to test “nonlinear” effects. O = Not looked at in KS model but available in PHTS data X = Looked at in KS model and not significant X = Significant in final KS model C = Suggested addition by Charlie Canter

Congenital Cardiomyopathy PHTS SRTR Clinical Condition at Donor Death: Donor Cause of Death: CVA O X Donor Cause of Death: CHT Donor Diuretics Donor Hematocrit Donor Serum Creatinine Note: All continuous variables had log and squared transformations to test “nonlinear” effects. O = Not looked at in KS model but available in PHTS data X = Looked at in KS model and not significant X = Significant in final KS model C = Suggested addition by Charlie Canter

Congenital Cardiomyopathy PHTS SRTR Mismatches: Donor to Recipient Height Ratio O X Donor to Recipient Weight Ratio Donor to Recipient BSA Ratio Note: All continuous variables had log and squared transformations to test “nonlinear” effects. O = Not looked at in KS model but available in PHTS data X = Looked at in KS model and not significant X = Significant in final KS model C = Suggested addition by Charlie Canter

Congenital Diagnosis ( n=1426) Year of Transplant n Graft loss at 1 year % 1999 – 2001 190 33 17.4% 2002 – 2004 230 45 20.0% 2005 – 2007 234 48 20.5% 2008 – 2010 353 50 14.2% 2011 – 2013 419 47 11.2% Total 1426 223 15.6% P(difference) = 0.007 P(trend) = 0.002

Congenital Diagnosis ( n=1426) Previous Fontan Operation n Graft loss at 1 year % Yes 327 55 16.8% No 1099 168 15.3% Total 1426 223 15.6% P(difference) = 0.50

Congenital Diagnosis ( n=1426) Fontan Patients n Graft loss at 1 year % 1999 – 2001 46 8 17.4% 2002 – 2004 68 18 26.5% 2005 – 2007 45 11 24.4% 2008 – 2010 65 9 13.8% 2011 – 2013 103 8.7% Total 327 55 P(difference) = 0.02 P(trend) = 0.009

Congenital Diagnosis ( n=1426) Ventilator at Transplant n Graft loss at 1 year % Yes 312 89 28.5% No 1114 134 12.0% Total 1426 223 15.6% P(difference) <

Congenital Diagnosis ( n=1426) VAD at Transplant n Graft loss at 1 year % Yes 57 13 22.8% No 1369 210 15.3% Total 1426 223 15.6% P(difference) = 0.13

Congenital Diagnosis ( n=1426) Patients with no VAD at transplant Year of Transplant n Graft loss at 1 year % 1999 – 2001 187 33 17.6% 2002 – 2004 225 45 20.0% 2005 – 2007 226 46 20.4% 2008 – 2010 335 13.4% 2011 – 2013 396 41 10.4% Total 1369 210 15.3% P(difference) = 0.002 P(trend) =

Congenital Diagnosis ( n=1426) Patients with VAD at transplant Year of Transplant n Graft loss at 1 year % 1999 – 2001 3 0.0% 2002 – 2004 5 2005 – 2007 8 2 25.0% 2008 – 2010 18 27.8% 2011 – 2013 23 6 26.1% Total 57 13 22.8% P(difference) = 0.60 P(trend) = 0.19

Congenital Diagnosis ( n=1426) ECMO at Transplant n Graft loss at 1 year N % Yes 81 35 43.2% No 1345 188 14.0% Total 1426 223 15.6% P(x2) <

Congenital Diagnosis ( n=1426) ECMO Patients n Graft loss at 1 year % 1999 – 2001 7 6 46.2% 2002 – 2004 13 35.0% 2005 – 2007 10 44.4% 2008 – 2010 14 8 66.7% 2011 – 2013 9 30.8% Total 46 35 P(difference) = 0.039 P(trend) = 0.94

Congenital Diagnosis ( n=1426) Donor cause of death: Cerebrovascular n Graft loss at 1 year % Yes 122 31 25.4% No 1299 191 14.7% Total 1421* 222 *5 unspecified causes of death P(difference) = 0.002

CHD Donor and Recipient Characteristics from PHTS and SRTR Models PHTS Primary Transplants Potential Risk Factors Predicting Graft Loss at 1 Year Post Transplant Characteristics at Transplant (Continuous Variables) Characteristics No Graft Loss n=1202 Graft Loss n=223 P-value Age at Transplant (years) 5.07 3.92 0.01 BMI at Transplant (kg/meter2) 16.68 16.24 0.25 BSA at Transplant (m2) 0.68 0.58 0.0032 Donor Age 6.38 5.62 0.20 Donor BMI (kg/meter2) 18.17 17.91 0.55 Donor BSA (m2) 0.82 0.71 Donor Ischemic Time 235.89 240.08 0.46 Number of Previous Cardiac Surgeries 2.39 2.38 0.99 Percent Reactive Antibody 15.51 19.89 0.09 Serum Albumin at Transplant (g/dL) 4.57 4.62 0.91 Total Bilirubin at Transplant(mg/dL) 1.85 3.12 0.07 Pulmonary Artery Mean at Transplant 24.69 24.08 0.83 Mean Pulmonary Capillary Wedge Pressure at Transplant 14.23 16.47 0.35 Blood Urea Nitrogen at Transplant (mg/dL) 18.07 23.04 <0.0001 Creatinine at Transplant (mg/dL) 0.53 0.86 Number of Years Since 1993 to Transplant 14.91 13.90 0.0012 Donor to Recipient Height Ratio 1.13 1.14 0.51

CHD Donor and Recipient Characteristics from PHTS and SRTR Models PHTS Primary Transplants Potential Risk Factors Predicting Graft Loss at 1 Year Post Transplant Characteristics at Transplant (Continuous Variables) Characteristics No Graft Loss Graft Loss P-value Single Ventricle 17.6% 21.5% 0.17 Male Donor 54.3% 57.5% 0.39 Donor on Inotropes, Pressors, or Thyroid Hormones 71.3% 72.2% 0.79 Donor Specific Crossmatch 15.4% 18.6% 0.31 Donor Race Black 20.6% 23.3% 0.36 Donor Race Non-white and Non-black 14.0% 13.9% 0.95 Donor Race White 70.1% 66.8% 0.33 Donor COD: Closed Head Trauma 41.7% 34.1% 0.03 Donor COD: Cerebrovascular 7.6% 0.0018 Fontan 22.6% 24.7% 0.50 Hepatitis B Surface Antibody 37.6% 32.9% 0.28 History of Cardiac Surgery at Listing 81.5% 82.1% 0.83 Male Recipient 59.6% 55.2% 0.22 Recipient Race Black 15.0% 17.9% 0.27 Recipient Race Non-white and Non-black 6.7% 10.8% Recipient Race White 78.6% Recipient Blood Type A 40.0% 33.3% 0.06 Recipient Blood Type AB 4.7% 4.5% 0.92 Recipient Blood Type B 11.7% 12.6% 0.69 Recipient Blood Type O 43.7% 49.5% 0.11 Status 1 at Transplant 89.0% 91.9% 0.19 In ICU at Transplant 42.2% 51.1% 0.01 In Hospital at Transplant 66.3% 77.6% 0.0009 High Dose Inotropes at Transplant 50.5% 52.5% 0.58 Low Dose Inotropes at Transplant 9.0% 0.23 Inotropes at Transplant 57.2% 61.4% 0.24 ECMO at Transplant 3.8% 15.7% <0.0001 VAD at Transplant 3.7% 5.8% 0.13 Ventilator at Transplant 18.5% 39.9%

Congenital Risk factors for graft loss at 1 year Odds Ratio P-value Demographics Female 1.33 0.07 Race = non-white, non-black 1.96 0.009 Surgical History Fontan operation 1.30 0.15 Medical Status at Transplant Not in ICU 1.37 0.10 Ventilator 2.66 <0.0001 ECMO 2.56 0.0007 BUN 1.01 0.005 Donor Ischemic time 1.001 0.14 CAV cause of death 1.85 0.01 Interactions* Date of transplant (earlier) 0.998 0.0009 VAD 0.232 0.18 Date * VAD 1.007 0.04 C statistic = *Must be interpreted simultaneously

CMP Donor and Recipient Characteristics from PHTS and SRTR Models PHTS Primary Transplants Potential Risk Factors Predicting Graft Loss at 1 Year Post Transplant Characteristics at Transplant (Categorical Variables) Characteristics No Graft Loss n=1406 Graft Loss n=95 P-value Age at Transplant (years) 8.08 6.97 0.10 BMI at Transplant (kg/meter2) 18.66 18.56 0.88 BSA at Transplant (m2) 1.01 0.93 0.18 Donor Age 11.25 11.46 Donor BMI (kg/meter2) 20.18 19.90 0.65 Donor BSA (m2) 1.17 1.07 0.11 Donor Ischemic Time 205.89 223.24 0.07 Number of Previous Cardiac Surgeries 1.44 1.11 0.04 Percent Reactive Antibody 6.10 15.75 0.03 Serum Albumin at Transplant (g/dL) 5.25 4.61 0.29 Total Bilirubin at Transplant(mg/dL) 1.66 5.28 0.30 Pulmonary Artery Mean at Transplant 28.46 36.33 0.05 Mean Pulmonary Capillary Wedge Pressure at Transplant 18.35 26.75 0.01 Blood Urea Nitrogen at Transplant (mg/dL) 17.67 23.25 0.02 Creatinine at Transplant (mg/dL) 0.84 0.75 0.58 Number of Years Since 1993 to Transplant 15.03 13.18 <0.0001 Donor to Recipient Weight Ratio 1.38 0.89 Donor to Recipient Height Ratio 1.10 0.62

CMP Donor and Recipient Characteristics from PHTS and SRTR Models PHTS Primary Transplants Potential Risk Factors Predicting Graft Loss at 1 Year Post Transplant Characteristics at Transplant (Categorical Variables) Characteristics No Graft Loss Graft Loss P-value Male Donor 60.2% 58.1% 0.69 Donor on Inotropes, Pressors, or Thyroid Hormones 74.6% 71.6% 0.52 Donor Specific Crossmatch 7.8% 10.6% 0.42 Donor Race Black 19.6% 20.0% 0.92 Donor Race Non-white and Non-black 12.2% 9.5% 0.43 Donor Race White 72.0% 76.8% 0.31 Donor COD: Closed Head Trauma 42.2% 38.9% 0.53 Donor COD: Cerebrovascular 11.0% 12.6% 0.62 Hepatitis B Surface Antibody 44.6% 38.7% 0.36 History of Cardiac Surgery at Listing 8.8% 0.21 Male Recipient 50.1% 42.1% 0.13 Recipient Race Black 24.7% 26.3% 0.73 Recipient Race Non-white and Non-black 11.6% 14.7% Recipient Race White 65.0% 58.9% 0.23 Recipient Blood Type A 36.1% 35.8% 0.96 Recipient Blood Type AB 3.3% 6.3% Recipient Blood Type B 14.9% 8.4% 0.08 Recipient Blood Type O 45.7% 49.5% 0.47 Status 1 at Transplant 92.0% 88.0% 0.18 In ICU at Transplant 44.9% 51.6% 0.20 In Hospital at Transplant 75.6% 0.37 High Dose Inotropes at Transplant 56.1% 45.3% 0.04 Low Dose Inotropes at Transplant 7.2% 0.40 Inotropes at Transplant 63.3% 54.7% 0.10 ECMO at Transplant <0.0001 VAD at Transplant 21.0% 24.2% 0.46 Ventilator at Transplant 14.8% 34.7% Dilated Cardiomyopathy 60.7% 44.2% 0.0016 Hypertrophic Cardiomyopathy 5.7% 0.02 Restrictive Cardiomyopathy 16.8%

Cardiomyopathy Risk Factors for Graft Loss at 1 year Odds Ratio P-value Demographics Female 1.59 0.04 Race: non-white 1.77 0.01 Age (younger) 0.76 0.002 Blood type: not B 2.43 0.03 Medical Condition at Transplant Restrictive cardiomyopathy 2.69 0.003 Hypertrophic cardiomyopathy 2.77 Previous cardiac surgery 1.68 0.14 Ventilator 2.67 0.0004 Not on inotropes 0.07 BUN (lower) 1.01 0.02 Donor Age (older) 1.001 Ischemic time (longer) Interactions * Transplant date (earlier) 0.89 < VAD - Date * VAD 1.04 C statistic = *Must be interpreted simultaneously

Summary Now have 2 new pediatric models Congenital and Cardiomyopathy Only data available in SRTR was included C-statistics both ≥ 0.7

Next Steps Meet with the writing group (last done in August, likely another soon) Further refine models Submit abstract/manuscript? Go to SRTR and discuss

Annual Fall Meeting November 13, 2016

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