33
DONOR MANAGEMENT: US Perspective CCCF October 26, 2015 Darren Malinoski, MD, FACS Assistant Chief of Surgery Portland VA Medical Center Associate Professor of Surgery Oregon Health & Science University *My views may not represent those of the U.S. Government

DONOR MANAGEMENT: US Perspective - Critical Care Canada … · 2019. 9. 27. · Dead / Re-Tx 4.8 mcg/hr Alive p value = 0.005 p value = 0.001 *Follow-up 684 + 392 days. Summary Predictors

  • Upload
    others

  • View
    1

  • Download
    0

Embed Size (px)

Citation preview

Page 2: DONOR MANAGEMENT: US Perspective - Critical Care Canada … · 2019. 9. 27. · Dead / Re-Tx 4.8 mcg/hr Alive p value = 0.005 p value = 0.001 *Follow-up 684 + 392 days. Summary Predictors

BACKGROUND

Shortage of organs for transplantation

National average of three organs transplanted per donor (OTPD)

30% of hearts utilized

Inconsistent donor management practices

Page 3: DONOR MANAGEMENT: US Perspective - Critical Care Canada … · 2019. 9. 27. · Dead / Re-Tx 4.8 mcg/hr Alive p value = 0.005 p value = 0.001 *Follow-up 684 + 392 days. Summary Predictors

BACKGROUND

Checklists have demonstrated utility in

several arenas

Standardized critical care endpoints

Donor Management Goals (DMGs)

Page 4: DONOR MANAGEMENT: US Perspective - Critical Care Canada … · 2019. 9. 27. · Dead / Re-Tx 4.8 mcg/hr Alive p value = 0.005 p value = 0.001 *Follow-up 684 + 392 days. Summary Predictors

OTPD and DMGs

Page 5: DONOR MANAGEMENT: US Perspective - Critical Care Canada … · 2019. 9. 27. · Dead / Re-Tx 4.8 mcg/hr Alive p value = 0.005 p value = 0.001 *Follow-up 684 + 392 days. Summary Predictors

UNOS Region 5 DMGs

Step 1 – retrospective – 2007-2008

Achieving Donor Management Goals (DMG) Prior to Deceased Donor Procurement is Associated with More Organs Transplanted per Donor

Primary outcome measure: > 4 OTPD

Page 6: DONOR MANAGEMENT: US Perspective - Critical Care Canada … · 2019. 9. 27. · Dead / Re-Tx 4.8 mcg/hr Alive p value = 0.005 p value = 0.001 *Follow-up 684 + 392 days. Summary Predictors

DMG/Variable OR 95% CI p value

Continuous Variables

Age (years) 0.944 0.923 – 0.966 < 0.001

Creatinine (mg/dL) 0.636 0.409 – 0.987 0.044

Categorical Variables

Thyroid Hormone use 1.969 1.082 – 3.582 0.026

CVP 4 – 10 mmHg 1.897 1.021 – 3.527 0.043

EF > 50% 3.988 2.095 – 7.592 < 0.001

P:F > 300 on PEEP 5 4.591 2.478 – 8.506 < 0.001

Na 135 – 160 mEq/L 3.352 1.141 – 9.851 0.028

“Goals met” 4.394 2.497 – 7.732 < 0.001

Page 7: DONOR MANAGEMENT: US Perspective - Critical Care Canada … · 2019. 9. 27. · Dead / Re-Tx 4.8 mcg/hr Alive p value = 0.005 p value = 0.001 *Follow-up 684 + 392 days. Summary Predictors

UNOS Region 5 DMGs

Step 2

Prospective

Three time points

At authorization for donation

12-18 hours later – organ offers being made

Prior to organ recovery

Modified DMGs

June 2008 – January 2009

Page 8: DONOR MANAGEMENT: US Perspective - Critical Care Canada … · 2019. 9. 27. · Dead / Re-Tx 4.8 mcg/hr Alive p value = 0.005 p value = 0.001 *Follow-up 684 + 392 days. Summary Predictors
Page 9: DONOR MANAGEMENT: US Perspective - Critical Care Canada … · 2019. 9. 27. · Dead / Re-Tx 4.8 mcg/hr Alive p value = 0.005 p value = 0.001 *Follow-up 684 + 392 days. Summary Predictors

UNOS Region 5 DMGs

Prospective Data 380 SCDs

The Impact of Meeting Donor Management Goals on the Number of Organs Transplanted per Donor Primary outcome measure: > 4 OTPD

Results confirmed findings of retrospective study

Page 10: DONOR MANAGEMENT: US Perspective - Critical Care Canada … · 2019. 9. 27. · Dead / Re-Tx 4.8 mcg/hr Alive p value = 0.005 p value = 0.001 *Follow-up 684 + 392 days. Summary Predictors

BACKGROUND

Organs transplanted per donor is not an

ideal outcome measure

Graft function is a better endpoint

Page 11: DONOR MANAGEMENT: US Perspective - Critical Care Canada … · 2019. 9. 27. · Dead / Re-Tx 4.8 mcg/hr Alive p value = 0.005 p value = 0.001 *Follow-up 684 + 392 days. Summary Predictors

Variable OR 95% CI p

Age (per year) 1.02 1.01-1.03 0.003

Creatinine prior to recovery (per mg/dL)

1.4 1.1-1.6 0.001

ECD 0.9 0.5-1.5 0.664

Cold ischemia time (per hour) 1.03 1.01-1.05 0.011

DMGs met at authorization 0.5 0.3-0.9 0.019

- 2013 American Journal of Transplantation

Page 12: DONOR MANAGEMENT: US Perspective - Critical Care Canada … · 2019. 9. 27. · Dead / Re-Tx 4.8 mcg/hr Alive p value = 0.005 p value = 0.001 *Follow-up 684 + 392 days. Summary Predictors

UNOS DMG Web PortalLaunched in March 2012 – supported by Tii

Forced field

entry

Linked to

UNet

Recipient

data added

Fields for

study data

Funded by

OPOs

SRTR SAF

merger *Now includes 14 OPOs from 7 UNOS Regions

Page 13: DONOR MANAGEMENT: US Perspective - Critical Care Canada … · 2019. 9. 27. · Dead / Re-Tx 4.8 mcg/hr Alive p value = 0.005 p value = 0.001 *Follow-up 684 + 392 days. Summary Predictors

Other recent publications from

the DMG Web Portal

Optimal Glucose Threshold = < 180 mg/dL

DMGs in ECDs

Propensity Analyses:

Hespan Use in the Donor on Recipient DGF

*Blood Transfusions in the Donor on DGF

*Predictors of cardiac graft outcomes

RCT:

Impact of Therapeutic Mild Hypothermia Prior to Organ Recovery on DGF

Page 14: DONOR MANAGEMENT: US Perspective - Critical Care Canada … · 2019. 9. 27. · Dead / Re-Tx 4.8 mcg/hr Alive p value = 0.005 p value = 0.001 *Follow-up 684 + 392 days. Summary Predictors

The Transfusion Effect Revisited: Impact of

Blood Transfusions in Deceased Organ

Donor on the Outcomes of 1884 Renal

Grafts from UNOS Region 5

J Salvador de la Cruz, John Zatarain, Mitch Sally,

Megan Crutchfield, Katrina Ramsay, Jodi Lapidus,

Susann Orloff, Darren Malinoski

Portland Veterans Affairs Medical Center

Oregon Health & Science University

Page 15: DONOR MANAGEMENT: US Perspective - Critical Care Canada … · 2019. 9. 27. · Dead / Re-Tx 4.8 mcg/hr Alive p value = 0.005 p value = 0.001 *Follow-up 684 + 392 days. Summary Predictors

Pre-Transplant Blood

Transfusion Historically: Kidney recipients given blood

transfusions prior to transplantation

Blood Transfusion and Kidney Transplant:

Results of Two Independent Studies

Patients without

Transfusion

Patients with

Transfusions

Year of Study 1 Year Graft

Survival

1 Year Graft

Survival

P value

1974 32% 53% 0.02

1976 31% 49% 0.01

Opelz G, Terasaki PI. Prog Clin Biol Res. 1976;11:133-40.

Page 16: DONOR MANAGEMENT: US Perspective - Critical Care Canada … · 2019. 9. 27. · Dead / Re-Tx 4.8 mcg/hr Alive p value = 0.005 p value = 0.001 *Follow-up 684 + 392 days. Summary Predictors

Transplanted Kidneys1,884

26% DGF rate250/975

34% DGF rate309/909

p<0.001

Results

Donor after Circulatory Death : 223< 18 years old: 177Separate trial: 183No kidney donated: 283Missing outcome data: 80

Total Donors(n=1,952)

DNDDs with > 1 kidney transplanted

(n=1,006)

Donors excluded N=946

≥1 unit of blood transfused975 (52%)

No blood transfused909 (48%)

Page 17: DONOR MANAGEMENT: US Perspective - Critical Care Canada … · 2019. 9. 27. · Dead / Re-Tx 4.8 mcg/hr Alive p value = 0.005 p value = 0.001 *Follow-up 684 + 392 days. Summary Predictors

Results:

Univariate Analysis – DGF

Categories of Number of Units of Blood Transfused

VariableNo Units

(n=909)

1-5 Units

(n=605)

6-10 Units

(n=198)

>10 Units

(n=172)p-value

DGF rate 34% 27% 25% 21% <0.001

Page 18: DONOR MANAGEMENT: US Perspective - Critical Care Canada … · 2019. 9. 27. · Dead / Re-Tx 4.8 mcg/hr Alive p value = 0.005 p value = 0.001 *Follow-up 684 + 392 days. Summary Predictors

Variable OR 95% CI for OR p-value

Blood Transfusion Category

Zero Units of Blood Ref -- --

1 to 5 Units of Blood 0.79 0.60 - 1.02 0.077

6 to 10 Units of Blood 0.79 0.52 - 1.20 0.281

Greater than 10 Units of Blood 0.56 0.35 - 0.91 0.019

Results:

Multivariate Analysis – DGF with

Propensity Score Included

Page 19: DONOR MANAGEMENT: US Perspective - Critical Care Canada … · 2019. 9. 27. · Dead / Re-Tx 4.8 mcg/hr Alive p value = 0.005 p value = 0.001 *Follow-up 684 + 392 days. Summary Predictors

Results:

Univariate Analysis – DGF

Page 20: DONOR MANAGEMENT: US Perspective - Critical Care Canada … · 2019. 9. 27. · Dead / Re-Tx 4.8 mcg/hr Alive p value = 0.005 p value = 0.001 *Follow-up 684 + 392 days. Summary Predictors

Impact of Donor Demographics and

Critical Care Endpoints on Cardiac

Transplantation and Recipient Survival

3433

DNDDs

2299 (67%)

Heart NOTTransplanted

1134 (33%)

Heart Transplanted

158 (14%)

Dead / Re-Tx

976 (86%)

Alive

*Follow-up 684 + 392

days

Page 21: DONOR MANAGEMENT: US Perspective - Critical Care Canada … · 2019. 9. 27. · Dead / Re-Tx 4.8 mcg/hr Alive p value = 0.005 p value = 0.001 *Follow-up 684 + 392 days. Summary Predictors

Impact of Donor Demographics and

Critical Care Endpoints on Cardiac

Transplantation and Recipient Survival

3433

DNDDs

2299 (67%)

Heart NOTTransplanted

1134 (33%)

Heart Transplanted

158 (14%)

Dead / Re-Tx

976 (86%)

Alive

*Follow-up 684 + 392 days

Page 22: DONOR MANAGEMENT: US Perspective - Critical Care Canada … · 2019. 9. 27. · Dead / Re-Tx 4.8 mcg/hr Alive p value = 0.005 p value = 0.001 *Follow-up 684 + 392 days. Summary Predictors

Multivariate Analysis: Predictors of Heart Transplantation

Page 23: DONOR MANAGEMENT: US Perspective - Critical Care Canada … · 2019. 9. 27. · Dead / Re-Tx 4.8 mcg/hr Alive p value = 0.005 p value = 0.001 *Follow-up 684 + 392 days. Summary Predictors

Multivariate Analysis: Predictors of Heart Transplantation

Page 24: DONOR MANAGEMENT: US Perspective - Critical Care Canada … · 2019. 9. 27. · Dead / Re-Tx 4.8 mcg/hr Alive p value = 0.005 p value = 0.001 *Follow-up 684 + 392 days. Summary Predictors

Multivariate Analysis: Predictors of Heart Transplantation

Page 25: DONOR MANAGEMENT: US Perspective - Critical Care Canada … · 2019. 9. 27. · Dead / Re-Tx 4.8 mcg/hr Alive p value = 0.005 p value = 0.001 *Follow-up 684 + 392 days. Summary Predictors

Impact of Donor Demographics and

Critical Care Endpoints on Cardiac

Transplantation and Recipient Survival

3433

DNDDs

2299 (67%)

Heart NOTTransplanted

1134 (33%)

Heart Transplanted

158 (14%)

Dead / Re-Tx

976 (86%)

Alive

*Follow-up 684 + 392 days

Page 26: DONOR MANAGEMENT: US Perspective - Critical Care Canada … · 2019. 9. 27. · Dead / Re-Tx 4.8 mcg/hr Alive p value = 0.005 p value = 0.001 *Follow-up 684 + 392 days. Summary Predictors

SRTR Data

Added:

Elements of

risk-adjusted

1-year Recipient

Survival Model

Page 27: DONOR MANAGEMENT: US Perspective - Critical Care Canada … · 2019. 9. 27. · Dead / Re-Tx 4.8 mcg/hr Alive p value = 0.005 p value = 0.001 *Follow-up 684 + 392 days. Summary Predictors

Multivariate Analysis: Predictors of Heart Recipient Survival*

Page 28: DONOR MANAGEMENT: US Perspective - Critical Care Canada … · 2019. 9. 27. · Dead / Re-Tx 4.8 mcg/hr Alive p value = 0.005 p value = 0.001 *Follow-up 684 + 392 days. Summary Predictors

Impact of Donor Demographics and

Critical Care Endpoints on Cardiac

Transplantation and Recipient Survival

Thyroid hormone dose

5.6 mcg/hr

Heart NOTTransplanted

4.5 mcg/hr

Heart Transplanted

2.9 mcg/hr

Dead / Re-Tx

4.8 mcg/hr

Alive

p value =

0.005

p value =

0.001

*Follow-up 684 + 392 days

Page 29: DONOR MANAGEMENT: US Perspective - Critical Care Canada … · 2019. 9. 27. · Dead / Re-Tx 4.8 mcg/hr Alive p value = 0.005 p value = 0.001 *Follow-up 684 + 392 days. Summary Predictors

Impact of Donor Demographics and

Critical Care Endpoints on Cardiac

Transplantation and Recipient Survival

Thyroid hormone dose

5.6 mcg/hr

Heart NOTTransplanted

4.5 mcg/hr

Heart Transplanted

2.9 mcg/hr

Dead / Re-Tx

4.8 mcg/hr

Alive

p value =

0.005

p value =

0.001

*Follow-up 684 + 392 days

Page 30: DONOR MANAGEMENT: US Perspective - Critical Care Canada … · 2019. 9. 27. · Dead / Re-Tx 4.8 mcg/hr Alive p value = 0.005 p value = 0.001 *Follow-up 684 + 392 days. Summary Predictors

Summary

Predictors of heart utilization:

Donor age, SCD, male, BMI <30, DMGs,

creatinine, pressors, thyroid hormone [less]

Page 31: DONOR MANAGEMENT: US Perspective - Critical Care Canada … · 2019. 9. 27. · Dead / Re-Tx 4.8 mcg/hr Alive p value = 0.005 p value = 0.001 *Follow-up 684 + 392 days. Summary Predictors

Summary

less

Predictors of heart survival

Donor age, SCD, male, DMGs, creatinine,

thyroid hormone [more] RCT needed

Page 32: DONOR MANAGEMENT: US Perspective - Critical Care Canada … · 2019. 9. 27. · Dead / Re-Tx 4.8 mcg/hr Alive p value = 0.005 p value = 0.001 *Follow-up 684 + 392 days. Summary Predictors

Summary

less

more

Mild hypothermia does not affect cardiac

graft utilization or recipient survival

Page 33: DONOR MANAGEMENT: US Perspective - Critical Care Canada … · 2019. 9. 27. · Dead / Re-Tx 4.8 mcg/hr Alive p value = 0.005 p value = 0.001 *Follow-up 684 + 392 days. Summary Predictors

Thank You

Darren Malinoski, MD, FACS

[email protected]